Clearance Summary
RefleXion Medical Radiotherapy System, Reflexion X2 received FDA 510(k) clearance under submission number K252071, sponsored by Reflexion Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-12-18.
- Submission: K252071
- Applicant / Sponsor: Reflexion Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5060
- Decision date: 2025-12-18
Classification & Regulation
This clearance is catalogued under FDA product code QVA and 21 CFR 892.5060, within the Radiology review panel as a Class II device.