510(k) K252071
- Device
- RefleXion Medical Radiotherapy System, Reflexion X2
- Applicant
- Reflexion Medical, Inc.
- 510(k) number
- K252071
- Product code
- QVA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-18
- Date received
- 2025-07-01
- Regulation
- 892.5060
- Classification name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Leena Kadakia
- Address
- 25881 Industrial Blvd. Suite 275 Hayward CA US 94545 94545
FDA Registration Numbers#
- 3011716550
Source Documents#
Other 510(k) Records For Product Code QVA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | 2023-02-01 |