Clearance Summary
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K852353, sponsored by Thomson-Cgr Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-08-07.
- Submission: K852353
- Applicant / Sponsor: Thomson-Cgr Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 1985-08-07
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.