THE MIDVIEW-MEDCON'S DICOM VIEWER— 510(k) K971181

Substantially Equivalent

Medcon , Ltd.

FDA 510(k) clearance K971181 for THE MIDVIEW-MEDCON'S DICOM VIEWER, Substantially Equivalent on 1997-07-29. Applicant: Medcon , Ltd..

Clearance details

Applicant: Medcon , Ltd.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1997-03-31
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

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.