Accelerator, Linear, Medical
Regulation 892.5050
15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
Top companies in IYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 18 | 206 |
| Varian Medical Systems | 83 | 27 |
| Elekta , Ltd. | 19 | 77 |
| Varian Medical Systems, Oncology Systems | 2 | 68 |
| Accuray Incorporated | 19 | 32 |
| Landauer | 1 | 39 |
| Brainlab | 22 | 17 |
| Varian Assoc., Inc. | 27 | 0 |
| Medtec, Inc. | 20 | 0 |
| Sun Nuclear Corp. | 19 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | PTW FREIBURG Brand Name: VERIQA;
Product Name: RT MonteCarlo 3D v3;
Model/Catalog Number: S070031.520;
Software Version: 3.1.18; Open, Classified |
IYE | K213370 |
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | K170788 |
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | K170788 |
| Jun 11, 2026 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K223229 |
| Jan 23, 2026 | Elekta, Inc. Brand Name: Elekta Medical Linear Accelerator
Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Software Version: N/A
Product Description: Digital Linear Accelerator
Component: N Open, Classified |
IYE | K210500 |
| Jan 14, 2026 | C-RAD POSITIONING AB Brand Name: Catalyst+
Product Name: Catalyst, Catalyst+
Model/Catalog Number: SP001-0026, SP003-0002
Software Version: cSRS module in combination with cMotion module
Product Description: GMDN: 40893 P Open, Classified |
IYE | K200435 |
| Jan 13, 2026 | Elekta, Inc. MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Open, Classified |
IYE | K203172 K223229 |
| Nov 14, 2025 | ELEKTA SOLUTIONS AB MOSAIQ Oncology Information System
Software Builds
3.1.3, 3.2.1, 3.2.2 & 3.2.3.0
Software Version and UDI Codes:
3.1.3.0 (01)07340201500026(10)3.1.3.0
3.1.3.1 (01)07340201500026(10)3.1.3.1
3.1.3.2 (0 Open, Classified |
IYE | K223229 |
| Sep 26, 2025 | Zap Surgical Systems ZAP-X Radiosurgery System, Model: 300150 Open, Classified |
IYE | K211663 |
| May 28, 2025 | C-RAD POSITIONING AB Brand Name: Catalyst+
Product Name: C4D software used in conjunction with
Catalyst (SP001-0025),
Catalyst HD (SP001-0026),
Catalyst PT (SP001-0027),
Catalyst X4 (SP002-0035),
Catalyst+ (SP003-0 Open, Classified |
IYE | K200435 |
| Apr 30, 2025 | IBA Dosimetry GmbH myQA iON; Article Number: MQ10-000; Open, Classified |
IYE | K201798 |
| Feb 12, 2025 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K223229 |
| Jan 27, 2025 | Accuray Incorporated CyberKnife Treatment Delivery System, REF 0660000
The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for i Completed |
IYE | K170788 |
| Sep 17, 2024 | Carbon Medical Technologies, Inc. BiomarC EX Fiducial Marker System, Catalog Number 040165 Open, Classified |
IYE | K132064 |
| Feb 22, 2024 | PTW-FREIBURG Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. Open, Classified |
IYE | K213370 |
| Dec 22, 2023 | Landauer Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 Completed |
IYE | K192196 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Sep 12, 2023 | Landauer Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer NanoDots, Model Numbers:
a) BC30023, description: QC Set For Microstar Dots;
b) BC30083, description: nanoDot QC Set - 80kVp - Sale;
c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Constancy (Cs-137) nanoDot D2DNN, Model Numbers:
a) 18155-000 (EMEA number VKITCON001);
b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Constancy (80 kVp) nanoDot D2DNN, Model Numbers:
a) 18150-000 (EMEA number VKITCON002);
b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (unexposed) nanoDot D2DNS, Model Numbers:
a) 18140-000;
b) 18140-KIT;
c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18135-000;
b) 18135-KIT;
c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18131-000;
b) 18131-KIT;
c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18130-000;
b) 18130-KIT;
c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18125-000;
b) 18125-KIT;
c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18121-000;
b)18121-KIT;
c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18120-000;
b) 18120-KIT;
c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 18105-000;
b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 18100-000;
b) 18100-1MO;
c) 18100-2MO;
d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN , Model Numbers:
a) 04293-000;
b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04225-000 (EMEA number VINLNAN005);
b) 04225-KIT;
c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04224-000 (EMEA number VINLNAN006);
b) 04224-KIT;
c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04218-000 (EMEA number VINLNAN004);
b) 04218-KIT;
c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04217-000 (EMEA number VINLNAN003);
b) 04217-KIT;
c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DXS, Model Numbers:
a) 03063-1MO;
b) 03063-3MO;
c) 03063-OTO;
d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
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