IYE — Accelerator, Linear, Medical Class II
FDA Device Classification
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 |
|---|
| 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 |
| K241937 | klarity medical and equipment (gz) co | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | March 18, 2025 |
| K242957 | varian medical systems | Identify (4.0) | February 7, 2025 |
| K240431 | brainlab | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | July 24, 2024 |
| K232738 | ptw-freiburg physikalisch-technische-werkstaetten dr. pychla | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080 | May 31, 2024 |
| K232923 | varian medical systems | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | April 30, 2024 |
| K232489 | linatech | VenusX | April 12, 2024 |