KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM— 510(k) K960043

Substantially Equivalent

Jamieson Film Co.

FDA 510(k) clearance K960043 for KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM, Substantially Equivalent on 1996-03-27. Applicant: Jamieson Film Co..

Clearance details

Applicant: Jamieson Film Co.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1996-01-03
Decision date: 1996-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.