510(k) · Radiology

Aorta-CAD

by Imagen Technologies, Inc

Aorta-CAD is an AI-enabled medical device from Imagen Technologies, Inc that the U.S. FDA cleared through 510(k) K213353 on September 20, 2022. Its lead review panel is Radiology and its primary product code is MYN (Analyzer, Medical Image).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK213353
Pathway510(k)
Date of final decision
Company (FDA list)Imagen Technologies, Inc
Lead review panelRadiology
Primary product codeMYN — Analyzer, Medical Image
Applicant (openFDA)Imagen Technologies, Inc.
Applicant locationNew York, NY, US
Device classClass 2
Regulation number21 CFR 892.2070
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Aorta-CAD went through this pathway (K213353).

openFDA lists it as a Class 2 device under 21 CFR 892.2070. Class II devices are moderate risk and are subject to general and special controls.

Product code MYN covers 43 devices on the FDA AI list. By decision date, this device is #12 of 43 under that code. Imagen Technologies, Inc has 6 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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