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FDA 510(k)

CT Cardiomegaly

K-Number: K232613 · 2024-02-28

ApplicantInnolitics, LLC
Decision Date2024-02-28
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT Cardiomegaly is a medical device manufactured by Innolitics, LLC. It received FDA 510(k) clearance on 2024-02-28 under approval number K232613. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT Cardiomegaly?

CT Cardiomegaly is a medical device that received FDA 510(k) clearance on 2024-02-28. It is manufactured by Innolitics, LLC. The 510(k) number is K232613.

When was CT Cardiomegaly approved by the FDA?

CT Cardiomegaly received FDA 510(k) clearance on 2024-02-28, under approval number K232613.

What company makes CT Cardiomegaly?

CT Cardiomegaly is manufactured by Innolitics, LLC.

What is the FDA product code for CT Cardiomegaly?

The FDA product code for CT Cardiomegaly is QIH.

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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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