# K212690: qXR-BT

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Dec 21, 2021 after 118 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: 7 generations back to K862120 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123526: Clearread +Confirm, Riverain Technologies (2012) Summary page 4.

## Indications for use
The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X-rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image.

Source page: https://510kreport.com/device/K212690
Methodology: https://510kreport.com/methodology