Clearance Summary
NORTHEAST PROTON THERAPY CENTER received FDA 510(k) clearance under submission number K983332, sponsored by Massachusetts General Hospital. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-07-20.
- Submission: K983332
- Applicant / Sponsor: Massachusetts General Hospital
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-07-20
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.