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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 the device name listed in this FDA 510(k) record. The listed applicant is Innolitics, LLC. It received FDA 510(k) clearance on 2024-02-28 under 510(k) 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. The listed applicant is Innolitics, LLC. The 510(k) number is K232613.

When did CT Cardiomegaly receive FDA 510(k) clearance?

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

Who is the listed applicant for CT Cardiomegaly?

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

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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