Clearance Summary
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY received FDA 510(k) clearance under submission number K032067, sponsored by Proxima Therapeutics, 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 2004-02-10.
- Submission: K032067
- Applicant / Sponsor: Proxima Therapeutics, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2004-02-10
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.