MAMMO WORKSTATION— 510(k) K081630

Substantially Equivalent

Image Diagnost International GmbH

FDA 510(k) clearance K081630 for MAMMO WORKSTATION, Substantially Equivalent on 2008-07-29. Applicant: Image Diagnost International GmbH.

Clearance details

Applicant: Image Diagnost International GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2008-06-11
Decision date: 2008-07-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Muenchen, DE

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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.