Clearance Summary
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) received FDA 510(k) clearance under submission number K041125, sponsored by Masep Med Science & Tech. Development (Shenzhen) C. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-12-30.
- Submission: K041125
- Applicant / Sponsor: Masep Med Science & Tech. Development (Shenzhen) C
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5750
- Decision date: 2004-12-30
Classification & Regulation
This clearance is catalogued under FDA product code IWB and 21 CFR 892.5750, within the Radiology review panel as a Class II device.