MATRIS INSTRU. VIDEO IMAGER 1010-— 510(k) K842494

Substantially Equivalent

Matrix Instruments

FDA 510(k) clearance K842494 for MATRIS INSTRU. VIDEO IMAGER 1010-, Substantially Equivalent on 1984-08-17. Applicant: Matrix Instruments.

Clearance details

Applicant: Matrix Instruments
Product code: Code IZI
Advisory panel: Radiology
Date received: 1984-06-26
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, 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.