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FDA 510(k)

IMAGENMD WITH IMAGENQ

K-Number: K080770 · 2008-04-09

ApplicantCardiovascular Imaging Technologies, LLC
Decision Date2008-04-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGENMD WITH IMAGENQ is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies, LLC. It received FDA 510(k) clearance on 2008-04-09 under 510(k) number K080770. 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 IMAGENMD WITH IMAGENQ?

IMAGENMD WITH IMAGENQ is a medical device that received FDA 510(k) clearance on 2008-04-09. The listed applicant is Cardiovascular Imaging Technologies, LLC. The 510(k) number is K080770.

When did IMAGENMD WITH IMAGENQ receive FDA 510(k) clearance?

IMAGENMD WITH IMAGENQ received FDA 510(k) clearance on 2008-04-09, under 510(k) number K080770.

Who is the listed applicant for IMAGENMD WITH IMAGENQ?

The FDA 510(k) record lists Cardiovascular Imaging Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGENMD WITH IMAGENQ?

The FDA product code for IMAGENMD WITH IMAGENQ is LLZ.

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Other records listing Cardiovascular Imaging Technologies, LLC 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.

K050366IMAGENPROK041671IMAGENMD

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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