Clearance Summary
Radiance 330 Proton Beam Therapy System received FDA 510(k) clearance under submission number K191521, sponsored by Protom International Holding Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-09-27.
- Submission: K191521
- Applicant / Sponsor: Protom International Holding Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2019-09-27
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.