Clearance Summary
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 received FDA 510(k) clearance under submission number K101508, sponsored by Ion Beam Applications S.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-08-06.
- Submission: K101508
- Applicant / Sponsor: Ion Beam Applications S.A.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2010-08-06
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.