Clearance Summary
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM received FDA 510(k) clearance under submission number K080004, sponsored by Sicel Technologies, 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 2008-01-23.
- Submission: K080004
- Applicant / Sponsor: Sicel Technologies, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2008-01-23
Classification & Regulation
This clearance is catalogued under FDA product code NZT and 21 CFR 892.5050, within the Radiology review panel as a Class II device.