CONTRAST ENHANCED DIGITAL MAMMOGRAPHY— 510(k) K123873

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K123873 for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY, Substantially Equivalent on 2013-01-29. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2012-12-17
Decision date: 2013-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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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.