IMAGENPRO— 510(k) K050366

Name: FDA 510(k) clearance K050366
Creator: U.S. Food and Drug Administration
Published: 2005-03-17

Substantially Equivalent

Cardiovascular Imaging Technologies, LLC

FDA 510(k) clearance K050366 for IMAGENPRO, Substantially Equivalent on 2005-03-17. Applicant: Cardiovascular Imaging Technologies, LLC. Device class: 2.

Clearance details

Applicant: Cardiovascular Imaging Technologies, LLC
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2005-02-14
Decision date: 2005-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lee'S Summit, MO, US

Download summary PDF View on FDA.gov ↗

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