SECTRA MICRODOSE MAMMOGRAPHY— 510(k) K110025

Substantially Equivalent

Sectra Imtec AB

FDA 510(k) clearance K110025 for SECTRA MICRODOSE MAMMOGRAPHY, Substantially Equivalent on 2011-04-28. Applicant: Sectra Imtec AB.

Clearance details

Applicant: Sectra Imtec AB
Product code: Code MUE
Advisory panel: Radiology
Date received: 2011-01-03
Decision date: 2011-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linkoping, 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.