Aorta-CAD— 510(k) K213353

Substantially Equivalent

Imagen Technologies, Inc.

FDA 510(k) clearance K213353 for Aorta-CAD, Substantially Equivalent on 2022-09-20. Applicant: Imagen Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Imagen Technologies, Inc.
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2021-10-08
Decision date: 2022-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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