MAMMODIAGNOST DR— 510(k) K110572

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K110572 for MAMMODIAGNOST DR, Substantially Equivalent on 2011-09-23. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code MUE
Advisory panel: Radiology
Date received: 2011-03-01
Decision date: 2011-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.