# K210666: Chest-CAD

- Pathway: 510(k) (Traditional)
- Applicant: Imagen Technologies, Inc.
- Decided: Jul 20, 2021 after 137 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: 1 generation back to P000041 (2001). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P000041: Rapidscreen RS-2000, Riverain Medical Group (2001) Summary page 5.

## Most influential descendants
- K213353: Aorta-CAD (2022), 2 descendants of its own
- K241620: ChestView US (2025), 1 descendant of its own
- K230085: Lung-CAD (2023), 1 descendant of its own
- K252486: ChestView US (1.1) (2026), 0 descendants of its own
- K251934: qXR-Detect (2026), 0 descendants of its own

## Indications for use
Chest-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious regions of interest (ROI). Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. The device is intended for use as a concurrent reading aid for physicians. Chest-CAD is indicated for adults only.

Source page: https://510kreport.com/device/K210666
Methodology: https://510kreport.com/methodology