Reflexion Medical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2486-2025 | Class II | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(1 | July 22, 2025 |
| Z-1933-2024 | Class II | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system i | April 16, 2024 |
| Z-0470-2022 | Class II | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics | November 24, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | December 18, 2025 |
| DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | February 1, 2023 |
| K190978 | RefleXion Medical Radiotherapy System | March 12, 2020 |