ImagenUniversal— 510(k) K173547

Name: FDA 510(k) clearance K173547
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Substantially Equivalent

Cardiovascular Imaging Technologies

FDA 510(k) clearance K173547 for ImagenUniversal, Substantially Equivalent on 2018-01-12. Applicant: Cardiovascular Imaging Technologies. Device class: 2.

Clearance details

Applicant: Cardiovascular Imaging Technologies
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2017-11-16
Decision date: 2018-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, UT, US

Download summary PDF View on FDA.gov ↗

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