KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)— 510(k) K120246

Name: FDA 510(k) clearance K120246
Creator: U.S. Food and Drug Administration
Published: 2012-08-28

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K120246 for KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN), Substantially Equivalent on 2012-08-28. Applicant: Carestream Health, Inc.. Device class: 2.

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2012-01-27
Decision date: 2012-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.