# K251934: qXR-Detect

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Jan 16, 2026 after 206 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 5.

## Indications for use
qXR-Detect is a computer-assisted detection (CADe) software device that analyzes chest radiographs and highlights suspicious regions of interest (ROIs). The device is intended to identify, highlight, and categorize suspicious regions of interest (ROI). Any suspicious ROI is highlighted by qXR-Detect and categorized into one of six categories (lung, pleura, bone, Mediastinum & Hila & Heart, hardware and other). The device is intended for use as a concurrent reading aid. qXR- Detect is indicated for adults only.

Source page: https://510kreport.com/device/K251934
Methodology: https://510kreport.com/methodology