# K223811: Lung-CAD

- Pathway: 510(k) (Traditional)
- Applicant: Imagen Technologies, Inc.
- Decided: Sep 13, 2023 after 267 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for interstitial thickening. The device uses a deep learning algorithm to identify regions of interest (ROIs) with interstitial thickening and produces boxes around the ROIs. Lung-CAD is intended for use as a concurrent reading aid for physicians interpreting chest X-rays. The device is not intended for clinical diagnosis of any disease. It does not replace the role of the physician or of other diagnostic testing in the standard of care for lung parenchymal findings. Lung-CAD is indicated for adults only.

Source page: https://510kreport.com/device/K223811
Methodology: https://510kreport.com/methodology