Clearance Summary
Beamscan MR received FDA 510(k) clearance under submission number K191646, sponsored by Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-02-21.
- Submission: K191646
- Applicant / Sponsor: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.