System, Tomography, Computed, Emission
FDA product code KPS · Class II (moderate risk) · 21 CFR 892.1200 · Radiology
473510(k) clearances
0PMA approvals
425recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 46
- Adac Laboratories 35
- GE Medical Systems, LLC 27
- Philips Medical Systems (Cleveland) Inc 20
- Shanghai United Imaging Healthcare Co., Ltd. 18
- Cti Pet Systems, Inc. 18
- Trionix Research Laboratory, Inc. 16
- Ge Medical Systems F.I. Haifa 14
- Syntermed, Inc. 13
- Hermes Medical Solutions AB 13
- GE Healthcare, LLC 12
- Digirad Corp. 10
- General Electric Co. 9
- Siemens Gammasonics, Inc. 9
- Nuccardiac Software, Inc. 7
- Smv America 7
- Is2 Research, Inc. 7
- Ultraspect , Ltd. 6
- Toshiba America Medical Systems, In.C 6
- Spectrum Dynamics Medical, Ltd. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 05/21/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/13/2026SE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | Spectrum Dynamics Medical, Ltd. | 01/13/2026SE |
| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | Hermes Medical Solutions AB | 09/09/2025SE |
| K250170 | PharosKPS · Traditional | Brightonix Imaging | 08/15/2025SE |
| K251561 | Biograph TrinionKPS · Special | Siemens Medical Solutions USA, Inc. | 07/31/2025SE |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/17/2025SE |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT SystemsKPS · Special | Siemens Medical Solutions USA, Inc. | 07/03/2025SE |
| K251153 | AuroraKPS · Traditional | Ge Medical Systems Israel | 06/12/2025SE |
| K243881 | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…KPS · Traditional | Bracco Diagnostics, Inc. | 03/03/2025SE |
| K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930)KPS · Traditional | Raysolution Healthcare Co., Ltd. | 01/27/2025SE |
| K243605 | AuroraKPS · Traditional | Ge Medical Systems Israel, Functional Imaging | 01/17/2025SE |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)KPS · Special | Shanghai United Imaging Healthcare Co., Ltd. | 12/12/2024SE |
| K241364 | Hybrid Viewer (00859873006189)KPS · Traditional | Hermes Medical Solutions AB | 11/08/2024SE |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 10/30/2024SE |
| K241585 | uMI PanoramaKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/30/2024SE |
| K241596 | uMI PanvivoKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/15/2024SE |
| K241665 | Omni LegendKPS · Traditional | Ge Medical Systems Israel, Functional Imaging | 08/08/2024SE |
| K241898 | Symbia SPECT and SPECT/CT SystemsKPS · Special | Siemens Healthineers | 07/26/2024SE |
| K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatKPS · Abbreviated | Positrigo AG | 07/15/2024SE |
| K240827 | SET-5002KPS · Abbreviated | Shimadzu Corporation Medical Systems Division | 05/24/2024SE |
| K231762 | uEXPLORERKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 01/18/2024SE |
| K233677 | Biograph VK10KPS · Traditional | Siemens Medical Solutions USA, Inc. | 01/12/2024SE |
| K232712 | uMI PanoramaKPS · Special | Shanghai United Imaging Healthcare Co., Ltd. | 10/03/2023SE |
| K232569 | CaremibrainKPS · Traditional | General Equipment For Medical Imaging, S.A. | 09/21/2023SE |
| K231576 | cNeuro cPETKPS · Traditional | Combinostics OY | 09/14/2023SE |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15KPS · Traditional | Canon Medical Systems Corporation | 09/12/2023SE |
| K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…KPS · Traditional | Mcgovern Medical School | 08/21/2023SE |
| K231572 | uMI PanoramaKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/26/2023SE |
| K231833 | Biograph Vision.X and Biograph Vision.X EdgeKPS · Special | Siemens Medical Solutions USA, Inc. | 07/13/2023SE |
| K231102 | Symbia Pro.specta VA20A FamilyKPS · Special | Siemens Medical Solutions USA, Inc. | 05/17/2023SE |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Abbreviated | Spectrum Dynamics Medical, Ltd. | 04/28/2023SE |
| K223212 | Precision DLKPS · Traditional | GE Healthcare | 04/27/2023SE |
| K223422 | Emory Cardiac Toolbox 4.3KPS · Special | Syntermed | 03/30/2023SE |
| K223325 | uMI PanoramaKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 03/10/2023SE |
| K223547 | Biograph Vision Quadra PET/CT SystemKPS · Special | Siemens Medical Solutions USA, Inc. | 12/22/2022SE |
| K222895 | DynamicIQKPS · Traditional | GE Medical Systems SCS | 11/22/2022SE |
| K221932 | Omni LegendKPS · Traditional | GE Healthcare | 09/02/2022SE |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsKPS · Traditional | Ever Fortune.Ai, Co., Ltd. | 05/31/2022SE |
| K214062 | Radialis PET CameraKPS · Traditional | Radialis, Inc. | 02/04/2022SE |
| K211964 | SubtlePETKPS · Traditional | Subtle Medical, Inc. | 09/28/2021SE |
| K212604 | Symbia VA10A FamilyKPS · Special | Siemens Medical Solutions USA, Inc. | 09/16/2021SE |
| K212004 | MyoSPECT, MyoSpect ESKPS · Traditional | GE Healthcare | 08/27/2021SE |
| K211846 | Discovery MI Gen2KPS · Traditional | Ge Medical Systems, LLC | 08/20/2021SE |
| K211764 | Vereos PET/CTKPS · Traditional | Philips Medical Systems Nederland B.V. | 08/06/2021SE |
| K211247 | PET VcarKPS · Traditional | GE Medical Systems SCS | 07/27/2021SE |
| K210880 | Vereos PET/CTKPS · Traditional | Philips Medical Systems Nederland B.V. | 05/19/2021SE |
| K210557 | Symbia VA10A FamilyKPS · Traditional | Siemens Medical Solutions USA, Inc. | 05/12/2021SE |
| K210001 | HYPER AiRKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/30/2021SE |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8KPS · Traditional | Canon Medical Systems Corporation | 04/23/2021SE |
| K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…KPS · Traditional | Mcgovern Medical School | 04/12/2021SE |
| K210418 | HYPER FocusKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/09/2021SE |
| K210173 | StarGuideKPS · Traditional | GE Healthcare | 03/29/2021SE |
| K210450 | BBX-PET ScannerKPS · Traditional | Prescient Imaging, LLC | 03/17/2021SE |
| K210262 | Biograph Vision Quadra PET/CT SystemKPS · Special | Siemens Medical Solutions USA, Inc. | 03/03/2021SE |
| K202882 | AffinityKPS · Traditional | Hermes Medical Solutions AB | 12/23/2020SE |
| K202392 | SIR-Spheres Microspheres Activity Calculator (SMAC)KPS · Traditional | Sirtex Medical US Holdings, Inc. | 10/23/2020SE |
| K202349 | Cartesion Prime, PCD-1000A, V10.7KPS · Traditional | Canon Medical Systems Corporation | 10/15/2020SE |
| K201807 | AncorisKPS · Traditional | Miegmbh | 08/27/2020SE |
| K201933 | ImagenSPECT 3.0KPS · Special | Cardiovascular Imaging Technologies | 08/11/2020SE |
| K193210 | Hyper DLRKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/04/2020SE |
| K200474 | Symbia 6.7KPS · Special | Siemens Medical Solutions USA, Inc. | 03/20/2020SE |
| K193248 | Biograph Vision, Biograph mCT Family of PET/CTsKPS · Traditional | Siemens Medical Solutions USA, Inc. | 02/14/2020SE |
| K193152 | AffinityKPS · Traditional | Hermes Medical Solutions AB | 02/14/2020SE |
| K192277 | CardIQ FlowKPS · Traditional | GE Medical Systems SCS | 02/14/2020SE |
| K193178 | Biograph HorizonKPS · Traditional | Siemens Medical Solution USA, Inc. | 02/12/2020SE |
| K193241 | Emission Computed Tomography SystemKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 01/26/2020SE |
| K191582 | Cartesion PrimeKPS · Traditional | Canon Medical Systems Corporation | 08/13/2019SE |
| K190457 | VERITON CT whole body SPECT/CT systemKPS · Traditional | Spectrum Dynamics Medical, Ltd. | 07/12/2019SE |
| K190900 | Biograph VisionKPS · Special | Siemens Medical Solutions USA, Inc. | 05/06/2019SE |
| K182938 | Emission Computed Tomography SystemKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 12/18/2018SE |
| K182336 | SubtlePETKPS · Traditional | Subtle Medical, Inc. | 11/30/2018SE |
| K182484 | VERITON CT whole body SPECT/CT systemKPS · Abbreviated | Spectrum Dynamics Medical, Ltd. | 11/09/2018SE |
| K181468 | Hybrid3DKPS · Traditional | Hermes Medical Solutions AB | 10/25/2018SE |
| K182237 | uMI 550 PET/CT SystemKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 10/12/2018SE |
| K180077 | NeuroQ 3.8KPS · Traditional | Syntermed | 08/16/2018SE |
| K181343 | HeartSee Cardiac P.E.T. Processing SoftwareKPS · Traditional | Bracco Diagnostics, Inc. | 06/12/2018SE |
| K180811 | Biograph VisionKPS · Traditional | Siemens Medical Solutions USA, Inc. | 05/23/2018SE |
| K180514 | Veriton NMKPS · Traditional | Spectrum Dynamics Medical, Ltd. | 04/25/2018SE |
| K173816 | Nm/Ct 850, Nm/Ct 860KPS · Traditional | GE Healthcare | 04/17/2018SE |
| K172143 | uMI 780 PET/CT SystemKPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/13/2018SE |
| K180318 | PET Digital GatingKPS · Traditional | Ge Medical Systems, LLC | 04/11/2018SE |
| K173547 | ImagenUniversalKPS · Traditional | Cardiovascular Imaging Technologies | 01/12/2018SE |
| K173578 | Biograph mCT Family of PET/CT SystemsKPS · Special | Siemens Medical Solutions USA, Inc. | 12/20/2017SE |
| K171719 | Hybrid3DKPS · Traditional | Hermes Medical Solutions AB | 11/21/2017SE |
| K171681 | Hermes Medical Imaging Suite v5.7KPS · Traditional | Hermes Medical Solutions AB | 11/21/2017SE |
| K173023 | Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldKPS · Traditional | Siemens Medical Solutions USA, Inc. | 11/17/2017SE |
| K172609 | CSMC Cardiac SuiteKPS · Special | Cedars-Sinai Medical Center | 11/03/2017SE |
| K172406 | Ingenuity TFKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 10/06/2017SE |
| K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664KPS · Traditional | University of Texas Medical School AT Houston… | 09/22/2017SE |
| K170904 | Biograph Horizon PET/CTKPS · Special | Siemens Medical Solutions USA, Inc. | 06/01/2017SE |
| K170490 | Celesteion, PCA-9000A/3KPS · Traditional | Toshibamedical Systems Corporation | 06/01/2017SE |
| K163394 | Hybrid3DKPS · Traditional | Hermes Medical Solutions AB | 05/22/2017SE |
| K162483 | Symbia Intevo BoldKPS · Traditional | Siemens Medical Solutions USA, Inc. | 01/09/2017SE |
| K161740 | D-SPECT Scanner, D-SPECT L ScannerKPS · Traditional | Spectrum Dynamics Medical, Ltd. | 11/04/2016SE |
| K162736 | Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTKPS · Traditional | Siemens Medical Solutions USA, Inc. | 10/25/2016SE |
| K161674 | QuantumCamKPS · Abbreviated | Ddd-Diagnostic A/S | 10/20/2016SE |
| K162337 | Symbia 6.5KPS · Special | Siemens Medical Solutions USA, Inc. | 09/08/2016SE |
| K161574 | Discovery MIKPS · Traditional | Ge Medical Systems, LLC | 08/11/2016SE |
| K161631 | MammiKPS · Special | General Equipment For Medical Imaging | 07/28/2016SE |
| K153056 | Hermes Medical Imaging Suite v5.6KPS · Traditional | Hermes Medical Solutions AB | 06/01/2016SE |
| K160120 | D-SPECT Processing and Reviewing WorkstationKPS · Traditional | Spectrum Dynamics , Ltd. | 03/21/2016SE |
| K152503 | ImagenSPECTKPS · Traditional | Cardiovascular Imaging Technologies | 01/25/2016SE |
| K153402 | Discovery NM/CT 670 CZTKPS · Traditional | GE Healthcare | 01/21/2016SE |
| K152880 | Biograph Horizon PET/CTKPS · Traditional | Siemens Medical Solutions USA, Inc. | 01/12/2016SE |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron…KPS · Traditional | Neusoft Medical Systems Co., Ltd. | 11/02/2015SE |
| K151486 | Biograph mCT and mCT Flow PET/CT ScannersKPS · Special | Siemens Medical Solutions USA, Inc. | 07/17/2015SE |
| K143664 | HeartSeeKPS · Traditional | University of Texas Medical School AT Houston | 04/14/2015SE |
| K142631 | Hermes Medical Imaging Suite v5.5KPS · Traditional | Hermes Medical Solutions AB | 12/18/2014SE |
| K141477 | Discovery IqKPS · Traditional | Ge Medical Systems, LLC | 09/18/2014SE |
| K141074 | Cortex Id SuiteKPS · Traditional | Ge Medical Systems, LLC | 09/18/2014SE |
| K141971 | Biograph True Pet/Ct Family SoftwareKPS · Special | Siemens Medical Solutions USA, Inc. | 09/12/2014SE |
| K142006 | Symbia 6.0KPS · Special | Siemens Medical Solutions USA, Inc. | 08/21/2014SE |
| K141652 | Cedars-Sinai Cardiac Suite Nuclear Medicine SoftwareKPS · Special | Cedars-Sinai Medical Center | 07/22/2014SE |
| K140996 | MammiKPS · Traditional | General Equipment For Medical Imaging (Oncovision- | 06/11/2014SE |
| K140651 | Celesteion, PCA-9000A/2KPS · Traditional | Toshibamedical Systems Corporation | 06/11/2014SE |
| K140269 | Hermes Medical Imaging Suite V5.4KPS · Traditional | Hermes Medical Solutions AB | 05/08/2014SE |
| K140206 | Scintillation Gamma CameraKPS · Traditional | Ddd-Diagnostic A/S | 05/08/2014SE |
| K133657 | Discovery Pet/Ct 710KPS · Traditional | Ge Medical Systems, LLC | 03/21/2014SE |
| K132347 | Multicam 3000 EcoKPS · Traditional | Inter Medical Medizintechnik GmbH | 11/20/2013SE |
| K131625 | Anyscan-S SPECT Imaging SystemKPS · Traditional | Absolute Imaging Solutions | 10/03/2013SE |
| K131634 | SymbiaKPS · Traditional | Siemens Medical Solutions USA, Inc. | 08/16/2013SE |
| K131233 | Hermes Medical Imaging Suite V5.3KPS · Traditional | Hermes Medical Solutions AB | 07/16/2013SE |
| K123599 | Ingenuity Digital Pet/CtKPS · Traditional | Philips Healthcare (Cleveland) | 07/12/2013SE |
| K130902 | Emory Cardiac Toolbox 3.2KPS · Traditional | Syntermed, Inc. | 06/14/2013SE |
| K130451 | Neuroq 3.6KPS · Traditional | Syntermed, Inc. | 05/17/2013SE |
| K130269 | Ecat Scintron PETKPS · Traditional | Miegmbh | 04/19/2013SE |
| K123433 | Cedars-Sinai Cardiac Suite Nuclear Medicine SoftwareKPS · Special | Cedars-Sinai Medical Center | 02/26/2013SE |
| K123646 | Emory Cardiac Toolbox 4.0KPS · Traditional | Syntermed, Inc. | 02/22/2013SE |
| K123737 | Biograph MCT FamilyKPS · Special | Siemens Medical Solutions USA, Inc. | 01/29/2013SE |
| K121278 | Hermes Medical Imaging Suite V5.2KPS · Special | Hermes Medical Solutions AB | 12/18/2012SE |
| K122241 | IMAGEN3DKPS · Traditional | Cardiovascular Imaging Technologies | 10/24/2012SE |
| K113754 | CFR QuantKPS · Traditional | University of Texas Medical School AT Houston | 07/19/2012SE |
| K121019 | Optima Nm/Ct 640KPS · Traditional | GE Healthcare | 04/19/2012SE |
| K113408 | Q. Freeze (Motion VUE2)KPS · Traditional | Ge Medical Systems, LLC | 02/24/2012SE |
| K113086 | AcqaKPS · Traditional | Texas Medical Imaging Consultants | 01/13/2012SE |
| K113448 | Biograph MCT FamilyKPS · Special | Siemens Medical Solutions USA, Inc. | 12/17/2011SE |
| K113350 | Brivo NM 615KPS · Special | GE Healthcare | 12/05/2011SE |
| K112474 | CSMC Cardiac Suite- Nuclear Medicine SoftwareKPS · Special | Cedars-Sinai Medical Center | 09/23/2011SE |
| K110507 | Cardiac Scanner and Processing SystemKPS · Traditional | Spectrum Dynamics (Israel) , Ltd. | 07/13/2011SE |
| K111445 | Discovery NM 630KPS · Traditional | GE Healthcare | 06/03/2011SE |
| K100714 | CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01KPS · Traditional | Cedars-Sinai Medical Center | 04/01/2011SE |
| K103710 | WBR Xpress PETKPS · Special | Ultraspect , Ltd. | 01/19/2011SE |
| K101768 | Mie Scintron Gamma Camera SystemsKPS · Traditional | Miegmbh | 10/05/2010SE |
| K101550 | Biograph MCT FamilyKPS · Traditional | Siemens Medical Solutions USA, Inc. | 09/03/2010SE |
| K101013 | Modification to Scintron IVKPS · Special | Miegmbh | 06/07/2010SE |
| K093514 | Discovery Model Nm/Ct 670KPS · Traditional | Ge Medical Systems F.I. Haifa | 12/10/2009SE |
| K090811 | Inspira HD, Model: NL1000KPS · Abbreviated | Neurologica Corporation | 08/27/2009SE |
| K091073 | WBR Xpress.Cardiac and XPRESS3.CARDIAC Including Attenuation and Scattering CorrectionsKPS · Special | Ultraspect , Ltd. | 05/14/2009SE |
| K091269 | NeuropetKPS · Traditional | Photodetection Systems, Inc. | 05/08/2009SE |
| K090178 | Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…KPS · Traditional | Neusoft Positron Medical Systems Co., Ltd. | 04/24/2009SE |
| K090553 | Naviscan Pemflex Solo II High Resolution PET ScannerKPS · Special | Naviscan, Inc. | 03/31/2009SE |
| K090403 | AutospectKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 03/31/2009SE |
| K083852 | Biograph 16 True Point SystemsKPS · Traditional | Siemens Medical Solutions USA, Inc. | 03/23/2009SE |
| K083649 | Cardius 3 X-ActKPS · Traditional | Digirad Corp. | 03/09/2009SE |
| K082904 | Stasys Motion Correction SoftwareKPS · Traditional | Digirad Corp. | 12/17/2008SE |
| K083504 | GE Discovery Nm/Ct 570CKPS · Traditional | Ge Medical Systems F.I. Haifa | 12/12/2008SE |
| K082506 | Symbia, Version 4.0KPS · Traditional | Siemens Medical Solutions USA, Inc. | 11/21/2008SE |
| K082354 | Stereo Navigator Accessory, STN-1000KPS · Traditional | Naviscan Pet Systems | 11/18/2008SE |
| K082581 | C-QuestKPS · Traditional | Medx, Inc. | 11/14/2008SE |
| K082368 | CARDIUS-1, -2, -3, and Cardius 1,2,3 Xpo SPECT Imaging Systems, 2020TC SPECT Imaging…KPS · Special | Digirad Corp. | 09/12/2008SE |
| K082244 | PCA-8000A, Mark 11, PET / CT SystemKPS · Traditional | Toshiba America Medical Systems, In.C | 08/21/2008SE |
| K081453 | Biograph HD FamilyKPS · Traditional | Siemens Medical Solutions USA, Inc. | 06/23/2008SE |
| K081496 | Optima Pet/Ct 560KPS · Traditional | Ge Medical Systems, LLC | 06/12/2008SE |
| K081426 | Nexstar Liftoff PET Application Software SuiteKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/04/2008SE |
| K081201 | WBR XPRESS3.CARDIACKPS · Special | Ultraspect , Ltd. | 05/28/2008SE |
| K080575 | CORRIDOR4DMKPS · Traditional | Invia | 05/13/2008SE |
| K081135 | Gemini CondorKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 04/29/2008SE |
| K080927 | Brightview VCT Imaging SystemKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 04/11/2008SE |
| K080784 | WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneKPS · Special | Ultraspect , Ltd. | 04/02/2008SE |
| K072307 | Quantitative Neuroq 3.0KPS · Traditional | Syntermed, Inc. | 03/14/2008SE |
| K080124 | Ventri 1.1KPS · Traditional | Ge Medical Systems F.I. Haifa | 01/31/2008SE |
| K073021 | Multi-SpectKPS · Traditional | Eagle Heart Imaging, LLC | 11/06/2007SE |
| K072567 | Symbia-E, Model 10275879KPS · Special | Siemens Medical Solutions USA, Inc. | 10/30/2007SE |
| K072191 | Clearvision Nuclear Medicine Imaging SystemKPS · Traditional | Gvi Technology Partners | 10/25/2007SE |
| K072468 | Modification to D-Spect Cardiac Scanner SystemKPS · Special | Spectrum Dynamics , Ltd. | 10/01/2007SE |
| K071503 | System, Tomography, Computed EmissionKPS · Traditional | Syntermed, Inc. | 07/26/2007SE |
| K071068 | Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197KPS · Special | Siemens Medical Solutions USA, Inc. | 05/14/2007SE |
| K070589 | C!KPS · Traditional | Transphoton Corporation | 04/24/2007SE |
| K070542 | Cardius 1, 2 and 3 Xpo and 2020TC SPECT Imaging SystemsKPS · Special | Digirad Corp. | 03/23/2007SE |
| K062450 | D-Spect Cardiac Scanner SystemKPS · Traditional | Spectrum Dynamics , Ltd. | 10/20/2006SE |
| K062393 | GE Vantage PET Neuro SoftwareKPS · Traditional | GE Healthcare | 09/01/2006SE |
| K062298 | Apollo Gamma Camera SystemKPS · Traditional | Adac Laboratories | 08/23/2006SE |
| K061545 | Scenium 1.1KPS · Special | Siemens Molecular Imaging, Ltd. | 06/30/2006SE |
| K061587 | Fullcard AnalysisKPS · Traditional | GE Healthcare | 06/23/2006SE |
| K060486 | Cyclone, Model Maicam 180KPS · Traditional | Spectrica | 03/23/2006SE |
| K060631 | Biograph 64 and Biograph 40KPS · Traditional | Siemens Medical Solutions USA, Inc. | 03/17/2006SE |
| K060060 | Biograph 6KPS · Special | Siemens Medical Solutions USA, Inc. | 02/03/2006SE |
| K053086 | Mie - Gamma Camera SystemsKPS · Traditional | Mie America, Inc. | 01/27/2006SE |
| K060020 | Autoquant PlusKPS · Traditional | Adac Laboratories | 01/20/2006SE |
| K053062 | Cardiarc SPECT Imaging Device, Model CQ103-RV2KPS · Traditional | Cardiarc , Ltd. | 01/06/2006SE |
| K052640 | Gemini RaptorKPS · Traditional | Philips Medical Systems (Cleveland), Inc. | 10/07/2005SE |
| K052430 | CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT Imaging SystemKPS · Special | Digirad Corp. | 10/04/2005SE |
| K052434 | Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraKPS · Special | GE Medical Systems | 09/27/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1112-2026 Class II | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend…There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking… | GE Medical Systems Israel, Functional Imaging | 12/24/2025Completed |
| Z-1047-2026 Class II | MAXXUS, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 12/10/2025Open, Classified |
| Z-1045-2026 Class II | SMV DSI, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 12/10/2025Open, Classified |
| Z-0303-2026 Class II | Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0302-2026 Class II | Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0301-2026 Class II | Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0300-2026 Class II | Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0299-2026 Class II | Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0298-2026 Class II | Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0297-2026 Class II | Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0296-2026 Class II | Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0295-2026 Class II | Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0294-2026 Class II | Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0293-2026 Class II | Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0292-2026 Class II | Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0291-2026 Class II | Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-0290-2026 Class II | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for…GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 09/12/2025Open, Classified |
| Z-2098-2025 Class II | Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine SystemUnintended radial detector motion may occur during patient setup or during patient scan if system does not… | GE Medical Systems Israel, Functional Imaging | 06/20/2025Open, Classified |
| Z-2097-2025 Class II | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine systemUnintended radial detector motion may occur during patient setup or during patient scan if system does not… | GE Medical Systems Israel, Functional Imaging | 06/20/2025Open, Classified |
| Z-0900-2025 Class II | GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0899-2025 Class II | GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0898-2025 Class II | GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0897-2025 Class II | GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0896-2025 Class II | GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0895-2025 Class II | GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0894-2025 Class II | GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0893-2025 Class II | GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0892-2025 Class II | GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0891-2025 Class II | GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0890-2025 Class II | GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0889-2025 Class II | GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0888-2025 Class II | GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4)…GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630… | GE Medical Systems Israel, Functional Imaging | 12/18/2024Open, Classified |
| Z-0678-2025 Class II | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software…Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a… | Hermes Medical Solutions AB | 10/31/2024Open, Classified |
| Z-0284-2025 Class II | Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic…When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET… | Canon Medical System, USA, INC. | 09/17/2024Open, Classified |
| Z-2040-2024 Class II | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and…There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the… | GE Medical Systems Israel, Functional Imaging | 04/15/2024Open, Classified |
| Z-0931-2024 Class I | BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit…Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of… | Philips North America | 12/15/2023Open, Classified |
| Z-0930-2024 Class I | BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format…Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of… | Philips North America | 12/15/2023Open, Classified |
| Z-0929-2024 Class I | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format…Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of… | Philips North America | 12/15/2023Open, Classified |
| Z-0679-2024 Class II | BrightView XCT, Gamma Camera, Product Code 882482While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the… | Philips North America | 11/30/2023Open, Classified |
| Z-0678-2024 Class II | BrightView X, Gamma Camera, Product Code 882478While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the… | Philips North America | 11/30/2023Open, Classified |
| Z-0677-2024 Class II | BrightView, Gamma Camera System, Product Code 882480.While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the… | Philips North America | 11/30/2023Open, Classified |
| Z-2256-2023 Class II | The following Pro.specta Emission Computed Tomography Systems that were manufactured…During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD)… | Siemens Medical Solutions USA, Inc. | 07/12/2023Open, Classified |
| Z-1353-2023 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and…Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail… | Shanghai United Imaging Healthcare Co., Ltd. | 03/01/2023Open, Classified |
| Z-1136-2023 Class II | SIEMENS Biograph Vision: a) 450, b) 600, c) 600 EdgeThis is a potential problem with the locking mechanism that is used to secure the PET gantry in either its… | Siemens Medical Solutions USA, Inc. | 01/16/2023Open, Classified |
| Z-1135-2023 Class II | SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic…This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its… | Siemens Medical Solutions USA, Inc. | 01/16/2023Open, Classified |
| Z-1134-2023 Class II | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, EmissionThis is a potential problem with the locking mechanism that is used to secure the PET gantry in either its… | Siemens Medical Solutions USA, Inc. | 01/16/2023Open, Classified |
| Z-1058-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c)…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | GE Medical Systems Israel, Functional Imaging | 12/19/2022Open, Classified |
| Z-1057-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | GE Medical Systems Israel, Functional Imaging | 12/19/2022Open, Classified |
| Z-1056-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | GE Medical Systems Israel, Functional Imaging | 12/19/2022Open, Classified |
| Z-1055-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | GE Medical Systems Israel, Functional Imaging | 12/19/2022Open, Classified |