ANGIOGRAPHIC X-RAY SYSTEM— 510(k) K922222

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K922222 for ANGIOGRAPHIC X-RAY SYSTEM, Substantially Equivalent on 1992-12-02. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant
Siemens Medical Solutions USA, Inc.
Product code
Code IZI
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Iselin, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IZI

product code IZI
Death
9
Malfunction
5,312
Total
5,321

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.