CT Cardiomegaly— 510(k) K232613

Substantially Equivalent

Innolitics, LLC

FDA 510(k) clearance K232613 for CT Cardiomegaly, Substantially Equivalent on 2024-02-28. Applicant: Innolitics, LLC.

Clearance details

Applicant
Innolitics, LLC
Product code
Code QIH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.