qXR-PTX-PE
K230899Qure.ai Technologies · cleared 2023-08-22 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.10)
“The qXR-PTX-PE is a software only device, similar to the predicate (Lunit INSIGHT CXR Triage).”
source quote (p.3)
“qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage.”
Validation studies (2)
Retrospective clinical
n=613 scans
endpoints: AUC; Sensitivity; Specificity
Retrospective clinical
n=1,070 scans
endpoints: AUC; Sensitivity; Specificity
Reported performance (6 observations)
source quote (p.9)
“Sensitivity 94.53 (90.42-97.24)”
source quote (p.9)
“Specificity 96.36 (94.07-97.95)”
source quote (p.9)
“AUC 98.94 95% CI (98.28 - 99.82)”
source quote (p.10)
“sensitivity 96.22 (93.62-97.97)”
source quote (p.10)
“specificity 94.90 (93.04-96.39)”
source quote (p.10)
“AUC 98.90 (98.47 - 99.44)”
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).