MAMMOWORKSTATION— 510(k) K123575

Substantially Equivalent

Image Diagnost International GmbH

FDA 510(k) clearance K123575 for MAMMOWORKSTATION, Substantially Equivalent on 2013-02-19. Applicant: Image Diagnost International GmbH.

Clearance details

Applicant: Image Diagnost International GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-11-20
Decision date: 2013-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.