DIGITAL MEDIA CONVERTER (D-MC)— 510(k) K935026

Substantially Equivalent

Eigen Video

FDA 510(k) clearance K935026 for DIGITAL MEDIA CONVERTER (D-MC), Substantially Equivalent on 1994-08-24. Applicant: Eigen Video.

Clearance details

Applicant: Eigen Video
Product code: Code IZI
Advisory panel: Radiology
Date received: 1993-10-20
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

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.