3 devices · 3 companies · 2020 to 2026
Product code IYE: Accelerator, Linear, Medical
3 devices under product code IYE, 2020 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Accelerator, Linear, Medical. 21 CFR 892.5050, Class II. MAUDE held 3,077 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| EMLAK252188 · 510(k) | Elekta Solutions AB | Radiology | database entry | |
| Ethos Treatment ManagementK232923 · 510(k) | Varian Medical Systems Inc. | Radiology | database entry | |
| Ethos Treatment Management, Ethos Treatment PlanK192377 · 510(k) | Varian Medical Systems, Inc. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.