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FDA 510(k)

VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION

K-Number: K070831 · 2007-05-22

ApplicantBarcoview Mis Edinburgh
Decision Date2007-05-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview Mis Edinburgh. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K070831. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION?

VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Barcoview Mis Edinburgh. The 510(k) number is K070831.

When did VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION receive FDA 510(k) clearance?

VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070831.

Who is the listed applicant for VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION?

The FDA 510(k) record lists Barcoview Mis Edinburgh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION?

The FDA product code for VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION is LLZ.

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Other records listing Barcoview Mis Edinburgh as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061326VOXAR 3D ENTERPRISE WITH CARDIAMETRIXK060505VOXAR 3D ENTERPRISE, MODEL 6.1

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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