Home › Device types › IYE
Accelerator, Linear, Medical
FDA product code IYE · Class 2 · Radiology
6,484
Registered devices
3,077
Adverse events
563
Recalls
738
510(k) clearances
Devices with this code
KLARITY MEDICAL — Klarity Medical Products, LLCHS PushPIN Basic Module Carbon — IT-V Medizintechnik GmbHHeadSTEP MR Basic Module — IT-V Medizintechnik GmbHX-MARK — Izi Medical Products, LLCAlignRT Plus — VISION RT LIMITEDAquaplast RT™ — QfixIVD 2 — SUN NUCLEAR CORP.Panther OIS|R&V — Prowess, Inc.Pronumbra — MEDTEC, INC.Orfit Industries — Orfit Industries NVKlarity Medical — Klarity Medical Products, LLCKLARITY MEDICAL — Klarity Medical Products, LLCPillow Tilt Small G — IT-V Medizintechnik GmbHNA — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHAquaplast RT™ — QfixHand Grip Pole for Varian — IT-V Medizintechnik GmbHShoulder Retractors — MEDTEC, INC.SureLock™ — CORTEX MANUFACTURING INC.Aquaplast RT™ — QfixOrfit — Orfit Industries NVHS S-TYPE Basic Module Carbon — IT-V Medizintechnik GmbHZap-X Treatment Delivery Software — ZAP SURGICAL SYSTEMS, INC.VISICOIL — Izi Medical Products, LLCKLARITY MEDICAL — Klarity Medical Products, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | PTW FREIBURG | When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may |
| 2026-06-16 | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the |
| 2026-06-16 | Accuray Incorporated | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the |
| 2026-05-21 | Elekta, Inc. | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| 2025-12-14 | Elekta, Inc. | Due to a manufacturing issue and electrical grounding of systems. |
| 2025-12-10 | Elekta, Inc. | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one fie |
| 2025-10-09 | C-RAD POSITIONING AB | Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the syst |
| 2025-09-17 | ELEKTA SOLUTIONS AB | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended sche |
| 2025-07-25 | Zap Surgical Systems | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occu |
| 2025-04-22 | C-RAD POSITIONING AB | Software issue with scanning equipment that can results in the filed rotation not being applied correctly. |
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