ImagenSPECT 3.0— 510(k) K201933

Name: FDA 510(k) clearance K201933
Creator: U.S. Food and Drug Administration
Published: 2020-08-11

Substantially Equivalent

Cardiovascular Imaging Technologies

FDA 510(k) clearance K201933 for ImagenSPECT 3.0, Substantially Equivalent on 2020-08-11. 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: 2020-07-13
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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