qXR-CTR
K231149Qure.ai Technologies · cleared 2023-09-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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.”
source quote (p.3)
“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.”
Validation studies (1)
Retrospective clinical
n=435 scans
endpoints: cardiac diameter; thoracic diameter; CTR
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K231805 (decision 2023-12-22) from Qure.ai Technologies for a matching device line ("qXR-LN") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231805
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).