ImagenSPECT— 510(k) K152503

Substantially Equivalent

Cardiovascular Imaging Technologies

FDA 510(k) clearance K152503 for ImagenSPECT, Substantially Equivalent on 2016-01-25. Applicant: Cardiovascular Imaging Technologies.

Clearance details

Applicant: Cardiovascular Imaging Technologies
Product code: Code KPS
Advisory panel: Radiology
Date received: 2015-09-02
Decision date: 2016-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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