IYE — Accelerator, Linear, Medical Class II
FDA product code IYE covers "Accelerator, Linear, Medical", a Class II medical device regulated under 21 CFR 892.5050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYE
- Device Class
- Class II
- Regulation Number
- 892.5050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252937 | dosisoft | ThinkQA 3 | June 12, 2026 |
| K253004 | lap gmbh laser applikationen | LUNA 3D | June 4, 2026 |
| K260792 | stabilix | AerFrame Patient Immobilization System (AFPIS) | May 8, 2026 |
| K252258 | ptw-freiburg physikalisch-technische-werkstaetten dr. pychla | VERIQA RT EPID 3D | April 15, 2026 |
| K253962 | radformation | ClearCheck (RADCC V2.7) | April 3, 2026 |
| K253012 | vision rt | AlignRT Plus (8.0) | March 18, 2026 |
| K252977 | varian medical systems | Halcyon, Ethos Radiotherapy System (5.0) | January 21, 2026 |
| K252188 | elekta solutions | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin | January 15, 2026 |
| K254010 | brainlab se | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | January 14, 2026 |
| K252988 | radformation | ChartCheck (RADCH V1.6) | January 5, 2026 |
| K252919 | varian medical systems | IDENTIFY (5.0) | December 16, 2025 |
| K250392 | zap surgical systems | ZAP-X Radiosurgery System (ZAP-X) | November 3, 2025 |
| K250696 | manteia technologies co | AccuCheck | October 24, 2025 |
| K250911 | electrogenics labs | MOSkin Radiation Measurement System | October 17, 2025 |
| K252948 | varian medical systems | TrueBeam, TrueBeam STX, Edge and VitalBeam | October 7, 2025 |
| K252174 | blessing cathay corporation | AquaCast Mask | September 3, 2025 |
| K243142 | brainlab | Cranial 4Pi Immobilization | June 23, 2025 |
| K243301 | vision rt | MapRT | May 19, 2025 |
| K250099 | varian medical systems | Mobius3D (4.1) | May 16, 2025 |
| K250429 | macromedics | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSP | March 19, 2025 |