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FDA 510(k)

CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)

K-Number: K082526 · 2009-01-05

ApplicantMri Cardiac Services, Incorporated
Decision Date2009-01-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) is the device name listed in this FDA 510(k) record. The listed applicant is Mri Cardiac Services, Incorporated. It received FDA 510(k) clearance on 2009-01-05 under 510(k) number K082526. 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 CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)?

CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) is a medical device that received FDA 510(k) clearance on 2009-01-05. The listed applicant is Mri Cardiac Services, Incorporated. The 510(k) number is K082526.

When did CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) receive FDA 510(k) clearance?

CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) received FDA 510(k) clearance on 2009-01-05, under 510(k) number K082526.

Who is the listed applicant for CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)?

The FDA 510(k) record lists Mri Cardiac Services, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)?

The FDA product code for CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) is LLZ.

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Other records listing Mri Cardiac Services, Incorporated 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.

K060840SVIEW

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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