510(k) DEN220014
- Device
- RefleXion Medical Radiotherapy System (RMRS)
- Applicant
- Reflexion Medical, Inc.
- 510(k) number
- DEN220014
- Product code
- QVA
- Decision
- Unknown (DENG)
- Decision date
- 2023-02-01
- Date received
- 2022-02-23
- Regulation
- 892.5060
- Classification name
- Fludeoxyglucose F18-Guided Radiation Therapy System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kathy O'Shaughnessy
- Address
- 25841 Industrial Blvd., Suite 275 Hayward CA US 94545 94545
FDA Registration Numbers#
- 3011716550
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QVA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | 2025-12-18 |