Accelerator, Linear, Medical
FDA product code IYE · Class II (moderate risk) · 21 CFR 892.5050 · Radiology
737510(k) clearances
0PMA approvals
553recalls
Manufacturers
- Varian Medical Systems, Inc. 83
- Varian Assoc., Inc. 27
- Brainlab AG 23
- Medtec, Inc. 20
- Elekta, Inc. 19
- Accuray Incorporated 19
- Sun Nuclear Corp. 19
- Siemens Medical Solutions USA, Inc. 18
- Nomos Corp. 12
- Vision Rt, Ltd. 11
- Philips Medical Systems 11
- Aktina Medical Physics Corp. 10
- Orfit Industries NV 10
- Bionix Development Corp. 10
- Siemens Medical Laboratories, Inc. 9
- Direx Systems Corp. 9
- Arplay Medical S.A. 8
- Radformation, Inc. 8
- Impac Medical Systems, Inc. 8
- Radionics, Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K252937 | ThinkQA 3IYE · Traditional | Dosisoft SA | 06/12/2026SE |
| K253004 | Luna 3DIYE · Traditional | Lap GmbH Laser Applikationen | 06/04/2026SE |
| K260792 | AerFrame Patient Immobilization System (AFPIS)IYE · Traditional | Stabilix, LLC | 05/08/2026SE |
| K252258 | Veriqa RT Epid 3DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 04/15/2026SE |
| K253962 | ClearCheck (RADCC V2.7)IYE · Traditional | Radformation, Inc. | 04/03/2026SE |
| K253012 | AlignRT Plus (8.0)IYE · Traditional | Vision Rt, Ltd. | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…IYE · Traditional | Elekta Solutions AB | 01/15/2026SE |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceIYE · Special | Brainlab SE | 01/14/2026SE |
| K252988 | ChartCheck (RADCH V1.6)IYE · Traditional | Radformation, Inc. | 01/05/2026SE |
| K252919 | Identify (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 12/16/2025SE |
| K250392 | ZAP-X Radiosurgery System (ZAP-X)IYE · Traditional | Zap Surgical Systems, Inc. | 11/03/2025SE |
| K250696 | AccuCheckIYE · Traditional | Manteia Technologies Co., Ltd. | 10/24/2025SE |
| K250911 | MOSkin Radiation Measurement SystemIYE · Traditional | Electrogenics Labs, Ltd. | 10/17/2025SE |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeamIYE · Traditional | Varian Medical Systems, Inc. | 10/07/2025SE |
| K252174 | AquaCast MaskIYE · Traditional | Blessing Cathay Corporation | 09/03/2025SE |
| K243142 | Cranial 4Pi ImmobilizationIYE · Traditional | Brainlab AG | 06/23/2025SE |
| K243301 | MapRTIYE · Traditional | Vision Rt, Ltd. | 05/19/2025SE |
| K250099 | Mobius3D (4.1)IYE · Traditional | Varian Medical Systems | 05/16/2025SE |
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…IYE · Traditional | Macromedics BV | 03/19/2025SE |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A)IYE · Traditional | Klarity Medical & Equipment (GZ) Co., Ltd. | 03/18/2025SE |
| K242957 | Identify (4.0)IYE · Traditional | Varian Medical Systems, Inc. | 02/07/2025SE |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceIYE · Traditional | Brainlab AG | 07/24/2024SE |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)IYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten… | 05/31/2024SE |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)IYE · Traditional | Varian Medical Systems, Inc. | 04/30/2024SE |
| K232489 | VenusXIYE · Traditional | Linatech, LLC | 04/12/2024SE |
| K233622 | AlignRT PlusIYE · Traditional | Vision Rt, Ltd. | 03/29/2024SE |
| K232031 | Luna 3DIYE · Traditional | Lap GmbH Laser Applikationen | 03/29/2024SE |
| K231573 | ThinkQA (Edition 2)IYE · Traditional | Dosisoft SA | 01/18/2024SE |
| K223234 | Delta4 InsightIYE · Traditional | Scandidos AB | 01/16/2024SE |
| K231273 | ArcherQA (V1.0)IYE · Traditional | Wisdom Technologies., Inc. | 01/05/2024SE |
| K232293 | kallisio stentra oral stentIYE · Traditional | Kallisio, Inc. | 12/22/2023SE |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)IYE · Traditional | Varian Medical Systems, Inc. | 12/21/2023SE |
| K231852 | BinkieRTIYE · Traditional | Papricalab | 11/15/2023SE |
| K232113 | Halcyon, Ethos Radiotherapy SystemIYE · Traditional | Varian Medical Systems, Inc. | 11/03/2023SE |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeamIYE · Traditional | Varian Medical Systems, Inc. | 09/12/2023SE |
| K230576 | IdentifyIYE · Traditional | Varian Medical Systems, Inc. | 07/25/2023SE |
| K223834 | AccuCheckIYE · Traditional | Manteia Technologies Co., Ltd. | 07/20/2023SE |
| K231185 | MapRTIYE · Traditional | Vision Rt, Ltd. | 06/23/2023SE |
| K223159 | Radixact Treatment Delivery SystemIYE · Traditional | Accuray Incorporated | 06/23/2023SE |
| K222762 | Siddharth-Ii;ImpactIYE · Traditional | Panacea Medical Technologies Pvt. , Ltd. | 06/08/2023SE |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeamIYE · Traditional | Varian Medical Systems, Inc. | 05/22/2023SE |
| K231052 | ExacTrac Dynamic 1.1.2IYE · Special | Brainlab AG | 05/11/2023SE |
| K230699 | ARIA Radiation Therapy Management (v18.0)IYE · Special | Varian Medical Systems, Inc. | 04/10/2023SE |
| K230312 | Iris AirShuttleIYE · Special | Qfix | 03/31/2023SE |
| K223229 | MOSAIQ® OIS (Oncology Information System)IYE · Traditional | Elekta Solutions AB | 02/23/2023SE |
| K223209 | Elekta UnityIYE · Traditional | Elekta Solutions AB | 02/23/2023SE |
| K222977 | DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStripIYE · Traditional | Macromedics BV | 02/17/2023SE |
| K222941 | Halcyon, Ethos Radiotherapy SystemIYE · Traditional | Varian Medical Systems, Inc. | 01/17/2023SE |
| K220539 | Klarity SRS Baseplate, Klarity Promise BaseplateIYE · Traditional | Klarity Medical & Equipment (GZ) Co., Ltd. | 11/01/2022SE |
| K220583 | ClearCheck Model RADCC V2IYE · Traditional | Radformation, Inc. | 08/23/2022SE |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTMIYE · Traditional | Macromedics BV | 06/24/2022SE |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3)IYE · Special | Varian Medical Systems, Inc. | 06/17/2022SE |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)IYE · Special | Varian Medical Systems, Inc. | 06/15/2022SE |
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeamIYE · Traditional | Varian Medical Systems, Inc. | 06/03/2022SE |
| K213137 | INTDoseIYE · Traditional | Carina Medical, LLC | 05/13/2022SE |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsIYE · Traditional | Macromedics BV | 05/11/2022SE |
| K213526 | Aurora-RTIYE · Traditional | Magnettx Oncology Solutions , Ltd. | 05/04/2022SE |
| K220338 | ExacTrac DynamicIYE · Traditional | Brainlab AG | 04/29/2022SE |
| K213370 | VeriqaIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 03/30/2022SE |
| K213053 | Gold AnchorIYE · Traditional | Naslund Medical AB | 01/06/2022SE |
| K212958 | MRIdian Linac SystemIYE · Traditional | Viewray, Incorporated | 12/14/2021SE |
| K212583 | AlignRT PlusIYE · Traditional | Vision Rt, Ltd. | 11/10/2021SE |
| K210921 | TaiChiBIYE · Traditional | Our United Corporation | 11/02/2021SE |
| K212114 | Elekta UnityIYE · Traditional | Elekta Solutions AB | 10/01/2021SE |
| K212794 | Accuray Precision Treatment Planning SystemIYE · Special | Accuray Incorporated | 09/30/2021SE |
| K211760 | Panther OISIYE · Traditional | Prowess, Inc. | 09/28/2021SE |
| K210894 | Siddharth-Ii; ImpactIYE · Traditional | Panacea Medical Technologies Pvt. , Ltd. | 09/28/2021SE |
| K212606 | BeamSiteIYE · Special | Doseoptics, LLC | 09/15/2021SE |
| K203722 | RayPilot SystemIYE · Traditional | Micropos Medical AB | 09/02/2021SE |
| K212294 | Ethos Treatment Management, Ethos Treatment PlanningIYE · Special | Varian Medical Systems, Inc. | 08/20/2021SE |
| K211663 | Zap-X Radiosurgical SystemIYE · Traditional | Zap Surgical Systems, Inc. | 07/29/2021SE |
| K211939 | ExacTrac DynamicIYE · Special | Brainlab AG | 07/22/2021SE |
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDIYE · Traditional | Elekta Limited | 06/11/2021SE |
| K211590 | Fiducial MarkerIYE · Special | Carbon Medical Technologies, Inc. | 06/10/2021SE |
| K211001 | C-Qual M Breastboard; Monarch Overhead Arm PositionerIYE · Traditional | Medtec, Inc. Dba Civco Medical Solutions and Civco | 05/20/2021SE |
| K202747 | Klarity BolusIYE · Traditional | Klarity Medical & Equipment (GZ) Co., Ltd. | 05/14/2021SE |
| K210835 | IdentifyIYE · Special | Varian Medical Systems, Inc. | 04/20/2021SE |
| K203387 | AlignRT PlusIYE · Traditional | Vision Rt, Ltd. | 03/04/2021SE |
| K203669 | Mobius3DIYE · Special | Varian Medical Systems, Inc. | 01/14/2021SE |
| K203172 | MOSAIQ Oncology Information SystemIYE · Traditional | Elekta Solutions AB | 12/18/2020SE |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery SystemIYE · Traditional | Accuray Incorporated | 12/18/2020SE |
| K200940 | BeamSiteIYE · Traditional | Doseoptics, LLC | 12/11/2020SE |
| K203173 | ExacTrac DynamicIYE · Special | Brainlab AG | 11/12/2020SE |
| K202050 | Cranial 4Pi ImmobilizationIYE · Special | Brainlab AG | 08/19/2020SE |
| K202068 | The AIO Solution 3.0IYE · Traditional | Orfit Industries NV | 08/14/2020SE |
| K193207 | TaiChiAIYE · Traditional | Our United Corporation | 08/07/2020SE |
| K201276 | ExacTrac DynamicIYE · Traditional | Brainlab AG | 07/13/2020SE |
| K200652 | Lollipop BiteBlockIYE · Traditional | Radtec Medical Devices, Inc. | 07/06/2020SE |
| K201119 | ChartCheckIYE · Traditional | Radformation, Inc. | 06/26/2020SE |
| K201117 | Gold AnchorIYE · Traditional | Naslund Medical AB | 06/11/2020SE |
| K200907 | Thales 3D Mr ScannerIYE · Traditional | Lap GmbH Laser Applikationen | 06/03/2020SE |
| K200435 | Catalyst+, Catalyst+ HDIYE · Traditional | C-Rad Positioning AB | 05/07/2020SE |
| K192405 | Image Guidance System for RadiotherapyIYE · Traditional | Jiangsu Rayer Medical Technology Co., Ltd. | 05/01/2020SE |
| K200600 | SentinelIYE · Special | C-Rad Positioning AB | 04/20/2020SE |
| K190978 | RefleXion Medical Radiotherapy SystemIYE · Traditional | Reflexion Medical, Inc. | 03/12/2020SE |
| K193243 | Alta Multipurpose DeviceIYE · Traditional | Qfix | 02/28/2020SE |
| K191646 | Beamscan MRIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 02/21/2020SE |
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonIYE · Traditional | Varian Medical Systems, Inc. | 02/10/2020SE |
| K193431 | AlignRT PlusIYE · Special | Vision Rt, Ltd. | 01/03/2020SE |
| K192196 | Medical Radiation Dosimetry System microSTARiiIYE · Traditional | Landauer | 12/27/2019SE |
| K192482 | Elekta UnityIYE · Traditional | Elekta Limited | 12/05/2019SE |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHDIYE · Traditional | Elekta Limited | 11/22/2019SE |
| K192968 | IdentifyIYE · Special | Varian Medical Systems, Inc. | 11/12/2019SE |
| K191944 | MU2netIYE · Traditional | Dosisoft | 10/24/2019SE |
| K192424 | Mobius3DIYE · Special | Varian Medical Systems, Inc. | 10/03/2019SE |
| K192102 | Thermoplastic MasksIYE · Traditional | Aktina Medical Corporation | 09/25/2019SE |
| K191158 | The AIO SolutionIYE · Traditional | Orfit Industries NV | 08/06/2019SE |
| K191267 | ImagingRing System on RailsIYE · Traditional | Medphoton GmbH | 08/01/2019SE |
| K191761 | Mobius3DIYE · Special | Varian Medical Systems, Inc. | 07/31/2019SE |
| K191797 | BiomarC Fiducial MarkerIYE · Special | Carbon Medical Technologies | 07/29/2019SE |
| K190137 | IdentifyIYE · Traditional | Varian Medical Systems, Inc. | 07/10/2019SE |
| K182374 | Liac SIYE · Traditional | Sit Sordina Iort Technologies Spa | 05/22/2019SE |
| K190894 | TOTIM Patient Cushion Immobilization SystemIYE · Traditional | Essebi Medical Srl | 04/30/2019SE |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)IYE · Traditional | Scandidos AB | 04/08/2019SE |
| K190155 | FibermarX Radiopaque Tissue MarkerIYE · Traditional | Viscus Biologics, LLC | 02/27/2019SE |
| K183374 | GrayDuck StentIYE · Traditional | Poll Medical, LLC | 02/26/2019SE |
| K183698 | Zap-X Radiosurgery SystemIYE · Traditional | Zap Surgical Systems | 02/25/2019SE |
| K181989 | MRIdian Linac SystemIYE · Traditional | Viewray, Incorporated | 02/20/2019SE |
| K183034 | MOSAIQ Oncology Information SystemIYE · Traditional | Elekta, Inc. | 12/04/2018SE |
| K182076 | Elekta UnityIYE · Traditional | Elekta Limited | 12/04/2018SE |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemIYE · Traditional | Accuray Incorporated | 11/23/2018SE |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS HeadframeIYE · Special | Qfix | 10/04/2018SE |
| K182050 | Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…IYE · Traditional | Siemens Medical Solutions USA, Inc. | 10/03/2018SE |
| K173926 | DORADOnova MR3TIYE · Traditional | Lap GmbH Laser Applikationen | 09/14/2018SE |
| K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…IYE · Traditional | Medtec Inc. Dba Civco Medical Solutions | 09/07/2018SE |
| K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDIYE · Traditional | Eleckta Limited | 09/05/2018SE |
| K181218 | AlignRT PlusIYE · Traditional | Vision Rt, Ltd. | 08/07/2018SE |
| K173848 | Model WP-3840 and WP-3040IYE · Traditional | Cnmc Co., Inc. | 08/07/2018SE |
| K180027 | ACCUSYTE 3D Fiducial MarkerIYE · Traditional | Radiation Products, LLC | 07/18/2018SE |
| K180697 | Pseudo-PatientIYE · Traditional | Rtsafe, Inc. | 07/10/2018SE |
| K180021 | Proton Positioing and Immobilization DevicesIYE · Traditional | Medtec Inc Dba Civco Medical Solutions and Civco… | 06/29/2018SE |
| K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorIYE · Special | Varian Medical Systems, Inc. | 06/28/2018SE |
| K172961 | Liac HWLIYE · Traditional | Sit Sordina Iort Technologies Spa | 06/11/2018SE |
| K181032 | HalcyonIYE · Special | Varian Medical Systems, Inc. | 05/09/2018SE |
| K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungIYE · Traditional | Varian Medical Systems, Inc. | 04/06/2018SE |
| K180595 | SciMoCaIYE · Traditional | Radialogica, LLC | 04/04/2018SE |
| K180586 | Varian Head FrameIYE · Special | Varian Medical Systems, Inc. | 04/02/2018SE |
| K180106 | ThinkQAIYE · Traditional | Dosisoft | 03/13/2018SE |
| K173838 | ARIA Radiation Therapy ManagementIYE · Special | Varian Medical Systems, Inc. | 01/17/2018SE |
| K173251 | LumiCoil Platinum Fiducial MarkerIYE · Traditional | Boston Scientific Corporation | 12/19/2017SE |
| K171352 | EZFluenceIYE · Traditional | Radformation, Inc. | 12/01/2017SE |
| K171350 | Collision CheckIYE · Traditional | Radformation, Inc. | 11/29/2017SE |
| K171467 | BioZorb Marker GOLD / LP Marker GOLDIYE · Traditional | Focal Therapeutics | 11/09/2017SE |
| K172534 | LINACwatch, LinacViewIYE · Traditional | Qualiformed Sarl | 10/27/2017SE |
| K170345 | SoftdisoIYE · Traditional | Best Nomos | 10/27/2017SE |
| K170307 | SunCHECKIYE · Traditional | Sun Nuclear Corporation | 10/25/2017SE |
| K160405 | Octavius I, Octavius II, Octavius III, Octavius 4DIYE · Traditional | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 10/20/2017SE |
| K171804 | Zap-X Radiosurgery SystemIYE · Traditional | Zap Surgical Systems | 09/21/2017SE |
| K172013 | VitalBeamIYE · Special | Varian Medical Systems, Inc. | 07/28/2017SE |
| K171837 | TomoTherapy Treatment Delivery System with iDMSIYE · Traditional | Accuray Incorporated | 07/25/2017SE |
| K171734 | HP PRO Positioning DeviceIYE · Traditional | Orfit Industries NV | 07/25/2017SE |
| K171733 | TrueBeam, TrueBeam STx, EdgeIYE · Special | Varian Medical Systems, Inc. | 07/12/2017SE |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE · Traditional | Qfix | 07/11/2017SE |
| K170817 | HalcyonIYE · Traditional | Varian Medical Systems, Inc. | 06/27/2017SE |
| K171086 | Accuray Precision Treatment Planning SystemIYE · Traditional | Accuray Incorporated | 06/08/2017SE |
| K170751 | MRIdian Linac System with 138-leaf CollimatorIYE · Traditional | Viewray, Incorporated | 06/07/2017SE |
| K161807 | BeamscanIYE · Traditional | Ptw-Freiburg Physikalisch Technische-Werksraetten | 05/19/2017SE |
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)IYE · Traditional | Radiomed Corporation | 04/28/2017SE |
| K170788 | CyberKnife Treatment Delivery SystemIYE · Traditional | Accuray Incorportaed | 04/11/2017SE |
| K170058 | TheraView TBIIYE · Special | Cablon Medical B.V. | 03/03/2017SE |
| K162393 | The ViewRay (MRIdian) Linac SystemIYE · Traditional | Viewray, Incorporated | 02/24/2017SE |
| K162472 | TrueBeam-TrueBeam STx-EdgeIYE · Traditional | Varian Medical Systems, Inc. | 01/19/2017SE |
| K162476 | Varian High Energy Linear AcceleratorIYE · Special | Varian Medical Systems, Inc. | 12/12/2016SE |
| K161400 | ImagingRing SystemIYE · Traditional | Medphoton GmbH | 12/08/2016SE |
| K162468 | ClearCheckIYE · Traditional | Radformation | 12/01/2016SE |
| K162355 | Raycast MammoRx Carbon Fibre Breast BoardIYE · Traditional | Orfit Industries NV | 11/22/2016SE |
| K162577 | Dosimetry Check Version 5 Release 1IYE · Traditional | Math Resolutions, LLC | 11/18/2016SE |
| K162265 | CushionCast Moldable CushionsIYE · Traditional | Izi Medical Products, LLC | 11/15/2016SE |
| K162862 | Raycast High Precision Lung Board SolutionIYE · Traditional | Orfit Industries NV | 11/09/2016SE |
| K162002 | Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam…IYE · Traditional | Zdi, Solutions, LLC | 11/01/2016SE |
| K162629 | IQM Integral Quality Monitor (also IQM)IYE · Traditional | Irt Systems | 10/20/2016SE |
| K161984 | Interlocked Circular Small Field Collimators, Elekta IntegratedIYE · Traditional | Aktina Medical Corporation | 09/27/2016SE |
| K161946 | DoseCHECKIYE · Traditional | Sun Nuclear Corporation | 09/16/2016SE |
| K161146 | Radixact Treatment Delivery SystemIYE · Traditional | Accuray Incorporated | 06/24/2016SE |
| K161144 | iDMS Data Management SystemIYE · Traditional | Accuray Incorporated | 06/24/2016SE |
| K160209 | Gold AnchorIYE · Traditional | Naslund Medical AB | 06/21/2016SE |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer…IYE · Traditional | Qfix | 06/14/2016SE |
| K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…IYE · Traditional | Medtec, Inc. D/B/A Civco Medical Solutions | 05/25/2016SE |
| K160057 | ArcCHECK-MRIYE · Traditional | Sun Nuclear Corporation | 05/13/2016SE |
| K153014 | Mobius3DIYE · Traditional | Mobius Medical Systems, LP | 04/29/2016SE |
| K153270 | TruGuard Custom Tongue and Jaw PositionerIYE · Traditional | Bionix Development Corp. | 03/08/2016SE |
| K152994 | AdaptivoIYE · Traditional | Aurora Technology Development, LLC | 02/03/2016SE |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+IYE · Traditional | Scandidos AB | 01/29/2016SE |
| K153011 | iViewDose R1.0IYE · Traditional | Elekta Limited | 12/11/2015SE |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass…IYE · Traditional | Qfix | 12/04/2015SE |
| K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…IYE · Special | Varian Medical Systems, Inc. | 11/25/2015SE |
| K142617 | ArcCHECKIYE · Traditional | Sun Nuclear Corporation | 11/20/2015SE |
| K151946 | ThermofitIYE · Traditional | Orfit Industries | 11/09/2015SE |
| K151882 | Varian Treatment (VTx)IYE · Traditional | Varian Medical Systems, Inc. | 10/26/2015SE |
| K152867 | MHI-TM2000 Linear Accelerator System, VERO, ImavisIYE · Special | Mitsubishi Heavy Industries, Ltd. | 10/21/2015SE |
| K143560 | CygneX I SystemIYE · Traditional | Accuthera, Inc. | 10/05/2015SE |
| K150382 | Radio Therapy Treatment ChairIYE · Traditional | Radiation Products Design, Inc. | 09/16/2015SE |
| K150265 | Model 206 Electrometer/DosimeterIYE · Traditional | Cnmc Company Incorporated | 09/03/2015SE |
| K151180 | ScandiDos Delta4 Phantom+IYE · Traditional | Scandidos AB | 08/19/2015SE |
| K150767 | EdoseIYE · Traditional | Guangzhou Raydose Software Technology., LLC | 08/17/2015SE |
| K151207 | Proton Immobilization SolutionIYE · Traditional | Orfit Industries NV | 07/28/2015SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3174-2026 | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number:…When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts… | PTW Freiburg | 08/04/2026Open, Classified |
| Z-2644-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | Accuray Incorporated | 06/16/2026Open, Classified |
| Z-2640-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | Accuray Incorporated | 06/16/2026Open, Classified |
| Z-2406-2026 Class II | MOSAIQ Oncology Information SystemSoftware may fail to load adapted baseline shift plan during treatment delivery when a communication error… | Elekta, Inc. | 05/21/2026Open, Classified |
| Z-1164-2026 Class II | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta…Due to a manufacturing issue and electrical grounding of systems. | Elekta, Inc. | 12/14/2025Open, Classified |
| Z-1078-2026 Class II | MOSAIQ Oncology Information System with Particle Therapy License (License Kit…Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with… | Elekta, Inc. | 12/10/2025Open, Classified |
| Z-1092-2026 Class II | Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number:…Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch… | C-Rad Positioning AB | 10/09/2025Open, Classified |
| Z-0503-2026 Class II | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0…When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of… | Elekta Solutions AB | 09/17/2025Open, Classified |
| Z-2639-2025 Class II | ZAP-X Radiosurgery System, Model: 300150If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180… | Zap Surgical Systems | 07/25/2025Open, Classified |
| Z-1858-2025 Class II | Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst…Software issue with scanning equipment that can results in the filed rotation not being applied correctly. | C-Rad Positioning AB | 04/22/2025Open, Classified |
| Z-1703-2025 Class II | myQA iON; Article Number: MQ10-000;Wrong analysis results can occur if the user creates two structures with the same name, except for one… | IBA Dosimetry GmbH | 04/01/2025Open, Classified |
| Z-1162-2025 Class II | MOSAIQ Oncology Information SystemImage offsets calculated by oncology Information System software may be incorrect for Linear Accelerator… | Elekta, Inc. | 01/15/2025Open, Classified |
| Z-1023-2025 Class II | CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled…Snap rings may become partially or completed detached from the shafts within the internal mechanism.… | Accuray Incorporated | 12/23/2024Completed |
| Z-3161-2024 Class III | BiomarC EX Fiducial Marker System, Catalog Number 040165This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the… | Carbon Medical Technologies, Inc. | 07/26/2024Open, Classified |
| Z-1181-2024 Class II | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation…Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress… | Ptw-Freiburg | 02/08/2024Open, Classified |
| Z-0616-2024 Class II | Landauer microSTARii reader, Medical Dosimetry System, Model Numbers:…MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible… | Landauer | 11/15/2023Completed |
| Z-0447-2024 Class II | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-0446-2024 Class II | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-0445-2024 Class II | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-0444-2024 Class II | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-0443-2024 Class II | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-0442-2024 Class II | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | Elekta, Inc. | 10/25/2023Open, Classified |
| Z-2489-2023 Class II | Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the…It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough… | Accuray Incorporated | 08/03/2023Completed |
| Z-2575-2023 Class II | Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2574-2023 Class II | NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2573-2023 Class II | NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2572-2023 Class II | Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2571-2023 Class II | Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2570-2023 Class II | Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2569-2023 Class II | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2568-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2567-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2566-2023 Class II | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2565-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2564-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2563-2023 Class II | nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2562-2023 Class II | nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2561-2023 Class II | nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2560-2023 Class II | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2559-2023 Class II | Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2558-2023 Class II | QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2557-2023 Class II | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003)…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2556-2023 Class II | nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2555-2023 Class II | nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2554-2023 Class II | nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2553-2023 Class II | nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2552-2023 Class II | QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2551-2023 Class II | QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2550-2023 Class II | Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |
| Z-2549-2023 Class II | Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring…LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of… | Landauer | 07/12/2023Completed |