# K231149: qXR-CTR

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Sep 22, 2023 after 154 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945512 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System, Ever Fortune.Ai, Co., Ltd. (2022) Summary page 4.

## Indications for use
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.

Source page: https://510kreport.com/device/K231149
Methodology: https://510kreport.com/methodology