FDA Product Code IZI: System, X-ray, Angiographic
Leading manufacturers include Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), Diagnostic Green GmbH and Aesculap, Inc..
FDA 510(k) Cleared System, X-ray, Angiographic Devices (Product Code IZI)
About Product Code IZI - Regulatory Context
510(k) Submission Activity
197 total 510(k) submissions under product code IZI since 1978, with 197 receiving FDA clearance (average review time: 102 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under IZI have taken an average of 285 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
IZI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →