Clearance Summary
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 received FDA 510(k) clearance under submission number K081066, sponsored by Medi-Physics, Inc., Dba GE Healthcare. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-05-05.
- Submission: K081066
- Applicant / Sponsor: Medi-Physics, Inc., Dba GE Healthcare
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2008-05-05
Classification & Regulation
This clearance is catalogued under FDA product code IWG and 21 CFR 892.5730, within the Radiology review panel as a Class II device.