Clearance Summary
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 received FDA 510(k) clearance under submission number K010472, sponsored by Thomson & Nielsen Electronics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-05-08.
- Submission: K010472
- Applicant / Sponsor: Thomson & Nielsen Electronics, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-05-08
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.