Clearance Summary
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) received FDA 510(k) clearance under submission number K163500, sponsored by Ion Beam Applications S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-08-17.
- Submission: K163500
- Applicant / Sponsor: Ion Beam Applications S.A.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2017-08-17
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.