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FDA 510(k)

VITREA CT MYOCARDIAL ANALYSIS

K-Number: K112531 · 2011-11-18

ApplicantVital Images, Inc.
Decision Date2011-11-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA CT MYOCARDIAL ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K112531. 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 VITREA CT MYOCARDIAL ANALYSIS?

VITREA CT MYOCARDIAL ANALYSIS is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Vital Images, Inc.. The 510(k) number is K112531.

When did VITREA CT MYOCARDIAL ANALYSIS receive FDA 510(k) clearance?

VITREA CT MYOCARDIAL ANALYSIS received FDA 510(k) clearance on 2011-11-18, under 510(k) number K112531.

Who is the listed applicant for VITREA CT MYOCARDIAL ANALYSIS?

The FDA 510(k) record lists Vital Images, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITREA CT MYOCARDIAL ANALYSIS?

The FDA product code for VITREA CT MYOCARDIAL ANALYSIS is LLZ.

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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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