BARCO MAMMO TOMOSYNTHESIS— 510(k) K103792

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K103792 for BARCO MAMMO TOMOSYNTHESIS, Substantially Equivalent on 2011-03-04. Applicant: Barco N.V..

Clearance details

Applicant: Barco N.V.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-12-27
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 8500 Kortrijk, BE

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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.