ClearanceBrief
Panels › Radiology › Product code IYE · Class 2

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)
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Top companies in IYE

DateFirm and productCodeLinked 510(k)
Sep 15, 2026PTW FREIBURG
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Open, Classified
IYEK213370
Jul 1, 2026Accuray Incorporated
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Open, Classified
IYEK170788
Jul 1, 2026Accuray Incorporated
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Open, Classified
IYEK170788
Jun 11, 2026Elekta, Inc.
MOSAIQ Oncology Information System
Open, Classified
IYEK223229
Jan 23, 2026Elekta, 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
IYEK210500
Jan 14, 2026C-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
IYEK200435
Jan 13, 2026Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Open, Classified
IYEK203172
K223229
Nov 14, 2025ELEKTA 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
IYEK223229
Sep 26, 2025Zap Surgical Systems
ZAP-X Radiosurgery System, Model: 300150
Open, Classified
IYEK211663
May 28, 2025C-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
IYEK200435
Apr 30, 2025IBA Dosimetry GmbH
myQA iON; Article Number: MQ10-000;
Open, Classified
IYEK201798
Feb 12, 2025Elekta, Inc.
MOSAIQ Oncology Information System
Open, Classified
IYEK223229
Jan 27, 2025Accuray 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
IYEK170788
Sep 17, 2024Carbon Medical Technologies, Inc.
BiomarC EX Fiducial Marker System, Catalog Number 040165
Open, Classified
IYEK132064
Feb 22, 2024PTW-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
IYEK213370
Dec 22, 2023Landauer
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Completed
IYEK192196
Dec 1, 2023Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Dec 1, 2023Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Dec 1, 2023Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Dec 1, 2023Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Dec 1, 2023Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Dec 1, 2023Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Open, Classified
IYEK210500
Sep 12, 2023Landauer
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196
Sep 12, 2023Landauer
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers
Completed
IYEK192196
Sep 12, 2023Landauer
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
IYEK192196

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