Company ยท US
Reflexion Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (1 in 12 months)
4recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2025 | K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 Reflexion Medical, Inc. | QVA |
| Feb 1, 2023 | DEN220014 | RefleXion Medical Radiotherapy System (RMRS) Reflexion Medical, Inc. | QVA |
| Mar 12, 2020 | K190978 | RefleXion Medical Radiotherapy System Reflexion Medical, Inc. | IYE |
Latest recalls
| 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 |
| Nov 24, 2021 | Reflexion Medical, Inc. RefleXion Medical Radiotherapy System -
System Label: "*** refleXion REF RXM1000 ***"
Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" Terminated |
IYE | K190978 |