Clearance Summary
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 received FDA 510(k) clearance under submission number K092285, sponsored by Best Medical Canada , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-08-28.
- Submission: K092285
- Applicant / Sponsor: Best Medical Canada , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2009-08-28
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.