K252071
- 510(k) number
- K252071
- Device name
- RefleXion Medical Radiotherapy System, Reflexion X2
- Applicant
- Reflexion Medical, Inc. CA · US
- Product code
- QVA — Fludeoxyglucose F18-Guided Radiation Therapy System
- Decision date
- 2025-12-18
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252071.pdf
Official FDA record: K252071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.