# K230085: Lung-CAD

- Pathway: 510(k) (Traditional)
- Applicant: Imagen Technologies, Inc.
- Decided: Oct 3, 2023 after 265 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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
- K243239: Lung AI (LAI001) (2025), 0 descendants of its own

## Indications for use
Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for lung hyperinflation. The device uses a deep learning algorithm to identify regions of interest (ROIs) with lung hyperinflation 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/K230085
Methodology: https://510kreport.com/methodology