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FDA 510(k)

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX

K-Number: K061326 · 2006-05-25

ApplicantBarcoview Mis Edinburgh
Decision Date2006-05-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX 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 2006-05-25 under 510(k) number K061326. 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 CARDIAMETRIX?

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Barcoview Mis Edinburgh. The 510(k) number is K061326.

When did VOXAR 3D ENTERPRISE WITH CARDIAMETRIX receive FDA 510(k) clearance?

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX received FDA 510(k) clearance on 2006-05-25, under 510(k) number K061326.

Who is the listed applicant for VOXAR 3D ENTERPRISE WITH CARDIAMETRIX?

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 CARDIAMETRIX?

The FDA product code for VOXAR 3D ENTERPRISE WITH CARDIAMETRIX 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.

K070831VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSIONK060505VOXAR 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

View on FDA Database →

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

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