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Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion

by Barcoview Mis Edinburgh

510(k) K070831

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070831 Date22 May 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion is a radiology device designed for advanced imaging analysis. It integrates 3D visualization capabilities with specialized tools for colon assessment and PET/CT perfusion evaluation.

The device is supplied as a software system for use in clinical imaging environments. It received FDA 510(k) clearance (K070831) on May 22, 2007, and is classified under product code LLZ. The system is intended for use by qualified healthcare professionals in radiology settings to support diagnostic interpretation of medical imaging data.

Other devices from Barcoview Mis Edinburgh

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion used for?

    Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion is a radiology device designed for advanced imaging analysis. It integrates 3D visualization capabilities with specialized tools for colon assessment and PET/CT perfusion evaluation to support diagnostic interpretation of medical imaging data by qualified healthcare professionals in radiology settings.

  • How is Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion supplied and deployed?

    The device is supplied as a software system intended for use in clinical imaging environments. It is designed to be installed and operated within existing radiology workflows to enable advanced image processing and analysis functions.

  • What regulatory clearance does Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion have?

    Voxar 3D Enterprise with Colonmetrix and PET/CT Perfusion received FDA 510(k) clearance (K070831) on May 22, 2007, and is classified under product code LLZ. The clearance was granted as substantially equivalent to a predicate device through a traditional review process.