510(k) K252071 ยท QVA Fludeoxyglucose F18-Guided Radiation Therapy System
RefleXion Medical Radiotherapy System, Reflexion X2
| Applicant | Reflexion Medical, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Dec 18, 2025 |
| Received | Jul 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252071
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.