QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS— 510(k) K023970

Substantially Equivalent

Medis Medical Imaging Systems BV

FDA 510(k) clearance K023970 for QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS, Substantially Equivalent on 2003-01-24. Applicant: Medis Medical Imaging Systems BV.

Clearance details

Applicant: Medis Medical Imaging Systems BV
Product code: Code IZI
Advisory panel: Radiology
Date received: 2002-11-29
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leiden, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.