qXR-Detect
K251934Qure.Ai Technologies · cleared 2026-01-16 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“qXR-Detect is a computer-assisted detection (CADe) software device that analyzes chest radiographs and highlights suspicious regions of interest (ROIs).”
source quote (p.7)
“Deep Learning”
source quote (p.11)
“The algorithm modifications will not include any adaptive algorithms that get continuously learn from the environment.”
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.6)
“The software works with DICOM chest X-ray images and can be deployed on a secure cloud server.”
Validation studies (2)
Standalone
sample size not stated
endpoints: AUC; localization accuracy; wAFROC
standards: ISO 13485: 2016, IEC 62304:2006+A1:2015
Reader study (MRMC)
n=301 cases
endpoints: wAFROC-FOM; number of false positives per image; AUC; Sensitivity; Specificity
Reported performance (4 observations)
source quote (p.10)
“0.9338 (0.9096-0.9579)”
source quote (p.10)
“0.6219 (0.5065-0.7373)”
source quote (p.10)
“0.8720 (0.8339-0.9100)”
source quote (p.10)
“0.3300 (0.3149 – 0.3457)”
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
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).