FDA Product Code
FDA Product Code QVA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5060
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | 2025-12-18 | Traditional | PDF ↗ |
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | 2023-02-01 | Direct | — |
Product code QVA · Class II · Radiology. Data: openFDA.