Fludeoxyglucose F18-Guided Radiation Therapy System
Regulation 892.5060
1510(k)s in 12 months (2 all time)
1recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in QVA
| Company | 510(k)s | Recalls |
|---|---|---|
| Reflexion Medical, Inc. | 2 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Reflexion Medical, Inc. RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 Open, Classified |
QVA | None listed |
| Sep 2, 2025 | Reflexion Medical, Inc. RefleXion X1 Model RXM1000
UDI Codes:
(01)00860003983812(11)230504(21)X11001
(01)00860003983812(11)230518(21)X11002
(01)00860003983812(11)230505(21)X11003
(01)00860003983812(11)230530(21)X11004
(01)00 Open, Classified |
QVA | None listed |
| May 30, 2024 | Reflexion Medical, Inc. RefleXion X1 Radiotherapy System Model RXM1000
Software version 2.1.19-3
Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a Open, Classified |
QVA | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.