VOXAR 3D ENTERPRISE WITH CARDIAMETRIX— 510(k) K061326

Substantially Equivalent

Barcoview Mis Edinburgh

FDA 510(k) clearance K061326 for VOXAR 3D ENTERPRISE WITH CARDIAMETRIX, Substantially Equivalent on 2006-05-25. Applicant: Barcoview Mis Edinburgh.

Clearance details

Applicant: Barcoview Mis Edinburgh
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-05-10
Decision date: 2006-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, Lothian, GB

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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.