MICRODOSE SI— 510(k) K123995

Substantially Equivalent

Philips Digital Mammography Sweden AB

FDA 510(k) clearance K123995 for MICRODOSE SI, Substantially Equivalent on 2013-02-01. Applicant: Philips Digital Mammography Sweden AB.

Clearance details

Applicant: Philips Digital Mammography Sweden AB
Product code: Code MUE
Advisory panel: Radiology
Date received: 2012-12-26
Decision date: 2013-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Solna, SE

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.