RefleXion Medical Radiotherapy System, Reflexion X2
FDA 510(k) clearance K252071 · decided 2025-12-18
Clearance details
- K-number
- K252071
- Device name
- RefleXion Medical Radiotherapy System, Reflexion X2
- Applicant
- Reflexion Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-01
- Decision date
- 2025-12-18
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- QVA
- Device class
- 2
- Regulation number
- 892.5060
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RefleXion Medical Radiotherapy System (RMRS) (DEN220014) | Reflexion Medical, Inc. | 2023-02-01 |
Recalls involving this device
No recalls on record reference this clearance.