Clearance Summary
EXPLORER 4D TREATMENT PLANNING SYSTEM received FDA 510(k) clearance under submission number K101220, sponsored by American Radiosurgery, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-11-05.
- Submission: K101220
- Applicant / Sponsor: American Radiosurgery, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2010-11-05
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.