KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT— 510(k) K970738

Substantially Equivalent

Jamieson Film Co.

FDA 510(k) clearance K970738 for KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT, Substantially Equivalent on 1997-05-07. Applicant: Jamieson Film Co..

Clearance details

Applicant: Jamieson Film Co.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1997-02-28
Decision date: 1997-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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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.