System, Nuclear Magnetic Resonance Imaging
FDA product code LNH · Class II (moderate risk) · 21 CFR 892.1000 · Radiology
1,105510(k) clearances
0PMA approvals
665recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 135
- GE Medical Systems, LLC 82
- Toshiba America Mri, Inc. 62
- Philips Medical Systems (Cleveland) Inc 57
- Hitachi Medical Systems America, Inc. 54
- Medical Advances, Inc. 38
- Canon Medical Systems Corporation 31
- General Electric Co. 29
- Esaote, S.p.A. 28
- Philips Medical Systems Nederland B.V. 27
- Shanghai United Imaging Healthcare Co., Ltd. 22
- Resonex, Inc. 21
- Philips Medical Systems North America, Inc. 19
- Elscint, Inc. 17
- Medrad, Inc. 16
- Philips Medical Systems 16
- Instrumentarium Imaging, Inc. 14
- Toshibamedical Systems Corporation 14
- Fonar Corp. 12
- Hyperfine, Inc. 12
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional | Xingaoyi Medical Equipment Co.,Ltd | 08/17/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260113 | uMR AstraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/22/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | Fujifilm Corporation | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | Esaote, S.p.A. | 03/27/2026SE |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 03/27/2026SE |
| K251937 | nordicAudio (1.0)LNH · Traditional | Nordicneurolab AS | 03/20/2026SE |
| K254277 | Embrace Neonatal MRI SystemLNH · Traditional | Aspect Imaging, Ltd. | 03/13/2026SE |
| K253413 | LiverMultiScan (v6.0)LNH · Traditional | Perspectum, Ltd. | 03/09/2026SE |
| K251901 | Magnifico Open (100009900)LNH · Traditional | Esaote, S.p.A. | 03/05/2026SE |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH · Special | Siemens Shenzhen Magnetic Resonance , Ltd. | 02/23/2026SE |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…LNH · Abbreviated | Philips Medical Systems Nederland B.V. | 02/23/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | Ge Medical Systems, LLC | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | Ge Medical Systems, LLC | 02/05/2026SE |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging SystemLNH · Traditional | Eyas Medical Imaging, Inc. | 01/26/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | Ge Medical Systems, LLC | 12/23/2025SE |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | Siemens Healthcare GmbH | 12/19/2025SE |
| K253489 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 12/12/2025SE |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 11/20/2025SE |
| K252371 | uMR 680LNH · Special | Shanghai United Imaging Healthcare Co., Ltd. | 09/25/2025SE |
| K251386 | ECHELON SynergyLNH · Traditional | Fujifilm Corporation | 09/17/2025SE |
| K251399 | SIGNA SprintLNH · Traditional | Ge Medical Systems, LLC | 09/11/2025SE |
| K251682 | MuscleView 2.0LNH · Traditional | Springbok, Inc. (Dba Springbok Analytics) | 09/09/2025SE |
| K251029 | Vista OS, Vista AI Scan, RTHawkLNH · Traditional | Vista AI, Inc. | 08/21/2025SE |
| K252239 | InVision 3T Recharge Operating SuiteLNH · Traditional | Imris Imaging, Inc. | 08/06/2025SE |
| K250246 | uMR JupiterLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/05/2025SE |
| K250901 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional | Canon Medical Systems Corporation | 07/22/2025SE |
| K243547 | uMR UltraLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/17/2025SE |
| K243397 | uMR 680LNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/16/2025SE |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia…LNH · Special | Philips Medical Systems Nederland B.V. | 07/11/2025SE |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH · Traditional | Siemens Healthcare GmbH | 06/16/2025SE |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 06/16/2025SE |
| K243667 | Sonic DLLNH · Traditional | Ge Medical Systems, LLC | 06/05/2025SE |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR…LNH · Special | Philips Medical Systems Nederland B.V. | 06/04/2025SE |
| K250236 | Swoop® Portable MR Imaging® System (V2)LNH · Traditional | Hyperfine, Inc. | 05/30/2025SE |
| K251276 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 05/21/2025SE |
| K243122 | uMR OmegaLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/21/2025SE |
| K250379 | SIGNA Prime EliteLNH · Traditional | Ge Medical Systems, LLC | 03/17/2025SE |
| K242006 | SureWave Elastography (Q7000225)LNH · Traditional | Quality Electrodynamics, LLC | 02/12/2025SE |
| K242825 | Prenuvo Body CompositionLNH · Traditional | Prenuvo | 01/17/2025SE |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 01/07/2025SE |
| K242573 | NIDO Baby Magnetic Resonance Imaging SystemLNH · Traditional | Jiangsu Lici Medical Device Co., Ltd. | 12/23/2024SE |
| K242524 | SyMRILNH · Traditional | Syntheticmr AB (Publ.) | 12/06/2024SE |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)LNH · Traditional | Asg Superconductors S.P.A. | 11/26/2024SE |
| K241242 | Signa MagnusLNH · Traditional | Ge Medical Systems, LLC | 10/17/2024SE |
| K241925 | VitruvianScan (v1.0)LNH · Traditional | Perspectum, Ltd. | 10/02/2024SE |
| K241331 | MuscleViewLNH · Traditional | Springbok, Inc. | 10/01/2024SE |
| K241607 | MyoStrain (6.0)LNH · Special | Myocardial Solutions, Inc. | 08/26/2024SE |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 08/20/2024SE |
| K241429 | ECHELON Synergy MRI SystemLNH · Traditional | Fujifilm Healthcare Corporation | 08/13/2024SE |
| K231133 | neo315LNH · Traditional | Neoscan Solution GmbH | 07/22/2024SE |
| K240944 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 07/16/2024SE |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH · Special | Esaote, S.p.A. | 06/26/2024SE |
| K233629 | APERTO Lucent MRI SystemLNH · Traditional | FUJIFILM Healthcare Americas Corporation | 05/10/2024SE |
| K233687 | ECHELON Synergy V10.0LNH · Traditional | FUJIFILM Healthcare Americas Corporation | 05/03/2024SE |
| K233673 | uMR JupiterLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/26/2024SE |
| K240571 | OASIS MRI SystemLNH · Traditional | Fujifilm Healthcare Corporation | 04/12/2024SE |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 04/12/2024SE |
| K240744 | uMR 680LNH · Special | Shanghai United Imaging Healthcare Co., Ltd. | 04/10/2024SE |
| K240608 | MAGNETOM Viato.MobileLNH · Special | Siemens Medical Solutions USA, Inc. | 03/29/2024SE |
| K233733 | SyMRILNH · Traditional | Syntheticmr AB (Publ.) | 03/26/2024SE |
| K240540 | uMR OmegaLNH · Special | Shanghai United Imaging Healthcare Co., Ltd. | 03/22/2024SE |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.XLNH · Traditional | Siemens Medical Solutions USA, Inc. | 03/22/2024SE |
| K232765 | MAGNETOM Cima.X FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 02/29/2024SE |
| K240157 | InVision 1.5 Surgical TheatreLNH · Traditional | Deerfield Imaging, Inc. | 02/15/2024SE |
| K232644 | neuro42 MRI SystemLNH · Traditional | Neuro42, Inc. | 02/08/2024SE |
| K233728 | SIGNA ChampionLNH · Traditional | Ge Healthcare (Tianjin) Company Limited | 01/19/2024SE |
| K232535 | MAGNETOM Sola; MAGNETOM AlteaLNH · Traditional | Siemens Medical Solutions USA, Inc. | 12/22/2023SE |
| K231587 | MAGNETOM Cima.XLNH · Traditional | Siemens Medical Solutions USA, Inc. | 12/18/2023SE |
| K232680 | fMRI Hardware SystemLNH · Traditional | Nordicneurolab AS | 12/13/2023SE |
| K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 11/14/2023SE |
| K231617 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Medical Solutions USA, Inc. | 11/09/2023SE |
| K232346 | Digital Expert Access with Remote ScanningLNH · Traditional | GE Healthcare | 10/27/2023SE |
| K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM…LNH · Traditional | Siemens Medical Solutions USA, Inc. | 10/23/2023SE |
| K232981 | Synq Software Version 1.3LNH · Traditional | Synaptive Medical, Inc. | 10/11/2023SE |
| K232760 | Swoop® Portable MR Imaging System®LNH · Special | Hyperfine, Inc. | 10/06/2023SE |
| K230187 | Terran NM-101LNH · Traditional | Terran Biosciences, Inc. | 09/29/2023SE |
| K232482 | MAGNETOM Viato.MobileLNH · Special | Siemens Medical Solutions USA, Inc. | 09/06/2023SE |
| K232361 | Promaxo MRI System IILNH · Special | Promaxo, Inc. | 09/05/2023SE |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 08/30/2023SE |
| K232030 | Ingenia Elition R5.7.1 SP4 MR SystemsLNH · Special | Philips Medical Systems Nederland B.V. | 08/02/2023SE |
| K223426 | ECHELON Synergy MRI systemLNH · Traditional | Fujifilm Healthcare Corporation | 07/13/2023SE |
| K231459 | HepaFatSmart (V2.0.0)LNH · Special | Resonance Health Analysis Services Pty, Ltd. | 06/20/2023SE |
| K223523 | Sonic DLLNH · Traditional | Ge Medical Systems,Llc (Ge Healthcare) | 05/30/2023SE |
| K230152 | uMR OmegaLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/23/2023SE |
| K230758 | uMR 570LNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/18/2023SE |
| K230972 | Ingenia Elition and MR 7700 MR SystemsLNH · Special | Philips Medical Systems Nederland B.V. | 04/28/2023SE |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsLNH · Abbreviated | Philips Medical Systems Nederland B.V. | 04/06/2023SE |
| K223343 | MAGNETOM Amira; MAGNETOM SempraLNH · Traditional | Siemens Medical Solutions USA, Inc. | 03/28/2023SE |
| K223875 | MOBINEURO Alita Intraoperative MRI SystemLNH · Traditional | Sino Canada Health Engineering Research… | 03/20/2023SE |
| K223203 | 1.5T 24E Posterior ArrayLNH · Traditional | Shenzhen RF Tech Co., Ltd. | 03/02/2023SE |
| K213805 | MAGNETOM VidaLNH · Traditional | Siemens Medical Solutions USA, Inc. | 02/24/2023SE |
| K230208 | Swoop® Portable MR Imaging SystemLNH · Special | Hyperfine, Inc. | 02/22/2023SE |
| K222259 | NEONA 1.5T MRI SystemLNH · Abbreviated | Time Medical Limited | 02/21/2023SE |
| K222755 | uMR 680LNH · Traditional | Shanghai United Imaging Intelligence Co., Ltd. | 02/16/2023SE |
| K223439 | SIGNA VictorLNH · Traditional | Ge Healthcare (Tianjin) Company Limited | 02/13/2023SE |
| K221619 | ECHELON Oval V6.2 MRI SystemLNH · Traditional | Fujifilm Healthcare Corporation | 01/26/2023SE |
| K223442 | MR 5300 and MR 7700 R11 MR SystemsLNH · Special | Philips Medical Systems Nederlands B.V. | 12/23/2022SE |
| K223247 | Swoop Portable MR Imaging SystemLNH · Special | Hyperfine, Inc. | 12/06/2022SE |
| K223079 | StageLNH · Special | Spintech, Inc. | 10/28/2022SE |
| K220332 | uMR Omega with uWS-MR-MRSLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 10/27/2022SE |
| K222968 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH · Special | Canon Medical Systems Corporation | 10/25/2022SE |
| K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 09/13/2022SE |
| K213960 | LiverMultiScan v5 (LMSv5)LNH · Traditional | Perspectum | 09/06/2022SE |
| K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH · Special | Canon Medical Systems Corporation | 08/31/2022SE |
| K221785 | TCL3 Motion Tracking SystemLNH · Traditional | Tracinnovations A/S | 08/29/2022SE |
| K221923 | Swoop Portable MR Imaging SystemLNH · Special | Hyperfine, Inc. | 07/28/2022SE |
| K203279 | Veuron-Brain-mN1LNH · Traditional | Heuron Co., Ltd. | 07/12/2022SE |
| K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemLNH · Traditional | Mri Division,Beijing Wandong Medical Technology… | 07/01/2022SE |
| K220575 | MAGNETOM Free.Max, MAGNETOM Free.StarLNH · Traditional | Siemens Medical Solutions USA, Inc. | 06/24/2022SE |
| K221393 | Swoop Portable MR Imaging SystemLNH · Special | Hyperfine, Inc. | 06/10/2022SE |
| K213717 | AIR Recon DLLNH · Traditional | Ge Medical Systems,Llc (Ge Healthcare) | 06/08/2022SE |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsLNH · Abbreviated | Philips Medical Systems Nederland B.V. | 05/16/2022SE |
| K220589 | MAGNETOM Skyra FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 05/13/2022SE |
| K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ALNH · Special | Siemens Medical Solutions USA, Inc. | 04/29/2022SE |
| K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 04/08/2022SE |
| K220335 | Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 04/05/2022SE |
| K220151 | MAGNETOM Avanto FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 04/01/2022SE |
| K220425 | MAGNETOM Vida, MAGNETOM SolaLNH · Traditional | Siemens Medical Solutions USA, Inc. | 03/11/2022SE |
| K220018 | MR Elastography; MZEK-001ALNH · Traditional | Canon Medical Systems Corporation | 03/03/2022SE |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiLNH · Abbreviated | Philips Medical Systems Nederland B.V. | 03/03/2022SE |
| K213693 | MAGNETOM Vida with syngo MR XA50ALNH · Traditional | Siemens Medical Solutions USA, Inc. | 02/25/2022SE |
| K213603 | SIGNA Artist EvoLNH · Traditional | Ge Healthcare (Tianjin) Company Limited | 02/11/2022SE |
| K212419 | Magnifico Open, Magnifico MSKLNH · Traditional | Esaote, S.p.A. | 02/04/2022SE |
| K212271 | smart-syncLNH · Traditional | Northh Medical GmbH | 02/04/2022SE |
| K213668 | SIGNA HeroLNH · Traditional | Ge Healthcare (Ge Medical Systems, LLC) | 01/20/2022SE |
| K211980 | SIGNA PrimeLNH · Traditional | Ge Healthcare (Tianjin) Company Limited | 01/16/2022SE |
| K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 12/01/2021SE |
| K211983 | AMRA ProfilerLNH · Traditional | Amra Medical AB | 11/24/2021SE |
| K212673 | MR 5300LNH · Abbreviated | Philips Medical Systems Nederland B.V. | 11/19/2021SE |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH · Traditional | Hyperfine, Inc. | 11/17/2021SE |
| K203372 | SyMRILNH · Traditional | Syntheticmr AB | 11/03/2021SE |
| K211406 | OASIS MRI SystemLNH · Traditional | Hitachi Healthcare Americas | 10/07/2021SE |
| K212233 | RTHawk, HeartVista Cardiac PackageLNH · Traditional | Heartvista, Inc. | 10/05/2021SE |
| K212367 | IMRIS iMRI 3T VLNH · Traditional | Deerfield Imaging, Inc. | 08/23/2021SE |
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 08/04/2021SE |
| K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 07/22/2021SE |
| K210415 | QSM software, QSMetricLNH · Traditional | Medimagemetric, LLC | 07/22/2021SE |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH · Special | Hyperfine, Inc. | 07/07/2021SE |
| K210611 | MAGNETOM Free.MaxLNH · Traditional | Siemens Medical Solutions USA, Inc. | 07/01/2021SE |
| K210843 | StageLNH · Traditional | Spintech, Inc. | 06/29/2021SE |
| K211037 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 05/17/2021SE |
| K211118 | Signa 7.0TLNH · Special | Ge Medical Systems, LLC | 05/13/2021SE |
| K203451 | TCL3 Motion Tracking SystemLNH · Traditional | Tracinnovations Aps | 04/28/2021SE |
| K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 04/01/2021SE |
| K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaLNH · Traditional | Siemens Medical Solutions USA, Inc. | 03/31/2021SE |
| K210164 | Vantage Elan 1.5T, MRT-2020, V6.0LNH · Traditional | Canon Medical Systems Corporation | 03/10/2021SE |
| K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 03/04/2021SE |
| K202518 | Promaxo MRI SystemLNH · Traditional | Promaxo, Inc. | 03/03/2021SE |
| K203653 | MRI PPG Patient CableLNH · Traditional | Ivy Biomedical Systems, Inc. | 03/02/2021SE |
| K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 02/02/2021SE |
| K192650 | i_Space 1.5T Superconducting Magnetic Resonance Imaging SystemLNH · Traditional | Mri Division,Beijing Wandong Medical Technology… | 01/29/2021SE |
| K202767 | Vantage Orian 1.5T, MRT-1550, V6.0LNH · Traditional | Canon Medical Systems Corporation | 01/15/2021SE |
| K203280 | Hepatica v1 (Hepatica v1.0.0)LNH · Traditional | Perspectum, Ltd. | 01/12/2021SE |
| K201039 | HepaFat-AILNH · Traditional | Resonance Health Analysis Services Pty, Ltd. | 12/07/2020SE |
| K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 12/02/2020SE |
| K202966 | SIGNA ArchitectLNH · Traditional | Ge Healthcare (Ge Medical Systems, LLC) | 11/13/2020SE |
| K202030 | OASIS MRI SystemLNH · Traditional | Hitachi Healthcare Americas | 10/21/2020SE |
| K201615 | Signa 7.0TLNH · Traditional | Ge Medical Systems, LLC | 10/15/2020SE |
| K202170 | LiverMultiScanLNH · Traditional | Perspectum, Ltd. | 10/02/2020SE |
| K202210 | Vantage Orian 1.5T, MRT-1550, V6.0LNH · Special | Canon Medical Systems Corporation | 09/22/2020SE |
| K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 09/08/2020SE |
| K202238 | SIGNA ArtistLNH · Special | Ge Healthcare (Tianjin) Company Limited | 09/04/2020SE |
| K201141 | FirmmLNH · Traditional | Nous Imaging, Inc. | 08/26/2020SE |
| K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH · Traditional | Hyperfine Research, Inc. | 08/11/2020SE |
| K201616 | SyMRILNH · Traditional | Syntheticmr AB | 07/28/2020SE |
| K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 07/14/2020SE |
| K201389 | Resoundant Acoustic Driver SystemLNH · Traditional | Resoundant, Inc. | 07/10/2020SE |
| K201540 | uMR570LNH · Special | Shanghai United Imaging Healthcare Co., Ltd. | 07/06/2020SE |
| K193021 | Vantage Orian 1.5T, MRT-1550, V6.0LNH · Traditional | Canon Medical Systems Corporation | 06/03/2020SE |
| K193176 | uMR 780LNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/05/2020SE |
| K200327 | EvryLNH · Traditional | Synaptive Medical, Inc. | 04/29/2020SE |
| K200024 | uMR 570LNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/20/2020SE |
| K193282 | SIGNA PremierLNH · Traditional | Ge Healthcare (Ge Medical Systems, LLC) | 04/10/2020SE |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsLNH · Abbreviated | Philips Medical Systems Nederland B.V. | 04/10/2020SE |
| K193218 | Innovision AudioLNH · Traditional | Innovere Medical, Inc. | 04/07/2020SE |
| K192852 | MRI ECG Patient CableLNH · Traditional | Ivy Biomedical Systems, Inc. | 03/28/2020SE |
| K193200 | uMR OmegaLNH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 03/27/2020SE |
| K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 03/11/2020SE |
| K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRLNH · Traditional | Canon Medical Systems Corporation | 03/09/2020SE |
| K192506 | Vantage Galan 3T, MRT-3020, V6.0LNH · Traditional | Canon Medical Systems Corporation | 03/02/2020SE |
| K192496 | Magnetom Sola, Magnetom Altea and Magnetom Sola FitLNH · Traditional | Siemens Medical Solutions USA, Inc. | 02/28/2020SE |
| K192851 | OASIS MRI SystemLNH · Traditional | Hitachi Healthcare Americas | 02/21/2020SE |
| K192002 | Lucy Point-of-Care Magnetic Resonance Imaging DeviceLNH · Traditional | Hyperfine Research, Inc. | 02/06/2020SE |
| K193324 | Motion Correction SystemLNH · Traditional | Kineticor, Inc. | 02/04/2020SE |
| K193102 | MRIaudio PREM System with MRIviewLNH · Traditional | Mriaudio, Inc. | 01/06/2020SE |
| K193116 | MRopen EVOLNH · Special | Asg Superconductors S.P.A. | 12/20/2019SE |
| K191032 | fMRI Hardware SystemLNH · Traditional | Nordicneurolab AS | 11/27/2019SE |
| K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 PlusLNH · Special | Asg Superconductors S.P.A. | 10/24/2019SE |
| K183274 | RTHawk, HeartVista Cardiac PackageLNH · Traditional | Heartvista, Inc. | 10/18/2019SE |
| K192426 | Signa Voyager, Signa Voyager QuantumLNH · Special | Ge Healthcare (Tianjin) Company Limited | 10/01/2019SE |
| K191662 | Vantage Orian 1.5T, MRT-1550, V4.5LNH · Special | Canon Medical Systems Corporation | 07/23/2019SE |
| K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease…LNH · Traditional | Siemens Medical Solutions USA, Inc. | 07/12/2019SE |
| K190524 | MRopen 0.5 TLNH · Traditional | Asg Superconductors S.P.A. | 07/01/2019SE |
| K190017 | LiverMultiScan (LMSv3)LNH · Traditional | Perspectum Diagnostics, Ltd. | 06/27/2019SE |
| K191128 | Vantage Titan 3T, MRT-3010, V2.5LNH · Traditional | Canon Medical Systems Corporation | 06/26/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3243-2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3242-2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3241-2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3240-2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3239-2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2.…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3238-2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3237-2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3236-2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3235-2026 | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3234-2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3233-2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3232-2026 | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-1969-2026 Class II | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1968-2026 Class II | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1967-2026 Class II | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1966-2026 Class II | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1965-2026 Class II | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1964-2026 Class II | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1963-2026 Class II | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1962-2026 Class II | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1961-2026 Class II | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1960-2026 Class II | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1959-2026 Class II | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1958-2026 Class II | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1957-2026 Class II | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1956-2026 Class II | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1955-2026 Class II | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1954-2026 Class II | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1953-2026 Class II | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1952-2026 Class II | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1951-2026 Class II | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | Philips North America | 04/14/2026Open, Classified |
| Z-1767-2026 Class II | SIGNA Premier systemsWhole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease… | GE Healthcare LLC | 02/27/2026Open, Classified |
| Z-1018-2026 Class II | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010There is a potential for formation of ice occurring in the venting system of the superconducting magnet of… | Canon Medical System, USA, INC. | 12/19/2025Open, Classified |
| Z-1017-2026 Class II | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020There is a potential for formation of ice occurring in the venting system of the superconducting magnet of… | Canon Medical System, USA, INC. | 12/19/2025Open, Classified |
| Z-1216-2026 Class II | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1215-2026 Class II | SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1214-2026 Class II | Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1213-2026 Class II | MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1212-2026 Class II | Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1211-2026 Class II | Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1210-2026 Class II | Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1209-2026 Class II | Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1208-2026 Class II | Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1207-2026 Class II | Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1206-2026 Class II | Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1205-2026 Class II | Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-1204-2026 Class II | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW…The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to… | Philips North America | 12/03/2025Open, Classified |
| Z-0327-2026 Class II | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.Affected system contains components that do not meet the required distance between electrodes for compliance… | Canon Medical System, USA, INC. | 10/16/2025Open, Classified |
| Z-0431-2026 Class I | MAGNETOM Cima.X Upgrade. Model Number: 11689304.There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary… | Siemens Medical Solutions USA, Inc | 10/01/2025Open, Classified |
| Z-0164-2026 Class I | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI…There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | IMPRIS Imaging Inc | 09/30/2025Open, Classified |