Clearance Summary
ISOCENTRIC NEUTRON THERAPY SYSTEMS received FDA 510(k) clearance under submission number K812337, sponsored by The Cyclotron Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-10-02.
- Submission: K812337
- Applicant / Sponsor: The Cyclotron Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5300
- Decision date: 1981-10-02
Classification & Regulation
This clearance is catalogued under FDA product code IWL and 21 CFR 892.5300, within the Radiology review panel as a Class II device.