Clearance Summary
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance under submission number K993766, sponsored by Helax AB. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-12-08.
- Submission: K993766
- Applicant / Sponsor: Helax AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1999-12-08
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.