# K213353: Aorta-CAD

- Pathway: 510(k) (Traditional)
- Applicant: Imagen Technologies, Inc.
- Decided: Sep 20, 2022 after 347 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P000041 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210666: Chest-CAD, Imagen Technologies, Inc. (2021) Summary page 6.

## Most influential descendants
- K241620: ChestView US (2025), 1 descendant of its own
- K252486: ChestView US (1.1) (2026), 0 descendants of its own

## Indications for use
Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta. Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.

Source page: https://510kreport.com/device/K213353
Methodology: https://510kreport.com/methodology