# K231805: qXR-LN

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Dec 22, 2023 after 185 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)
- K201560: Auto Lung Nodule Detection, Samsung Electronics Co., Ltd. (2021) Summary page 4.

## Indications for use
The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image.

Source page: https://510kreport.com/device/K231805
Methodology: https://510kreport.com/methodology