Clearance Summary
THERATRON EQUINOX, MODELS 80 CM AND 100 CM received FDA 510(k) clearance under submission number K053485, sponsored by Mds Nordion, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-03-09.
- Submission: K053485
- Applicant / Sponsor: Mds Nordion, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5750
- Decision date: 2006-03-09
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.