KODAK CARESTREAM PACS— 510(k) K053347

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K053347 for KODAK CARESTREAM PACS, Substantially Equivalent on 2006-01-04. Applicant: Eastman Kodak Company.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-12-02
Decision date: 2006-01-04
Decision: Substantially Equivalent
Clearance type: Special
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.