VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION— 510(k) K070831

Name: FDA 510(k) clearance K070831
Creator: U.S. Food and Drug Administration
Published: 2007-05-22

Substantially Equivalent

Barcoview Mis Edinburgh

FDA 510(k) clearance K070831 for VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION, Substantially Equivalent on 2007-05-22. Applicant: Barcoview Mis Edinburgh. Device class: 2.

Clearance details

Applicant: Barcoview Mis Edinburgh
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-03-26
Decision date: 2007-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, Lothian, GB

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K061326 — VOXAR 3D ENTERPRISE WITH CARDIAMETRIX2006-05-25
K060505 — VOXAR 3D ENTERPRISE, MODEL 6.12006-03-29

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.