qXR-LN

K231805

Qure.ai Technologies · cleared 2023-12-22 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.8)

“The qXR-LN is a software only device, similar to the predicate (Samsung Auto Lung Nodule Detection).”

Algorithmdeep learning algorithm

source quote (p.5)

“The device utilizes a deep learning algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

sample size not stated · 40 site(s)

endpoints: nodule-level sensitivity; overall FPPI; scan level AUC; Sensitivity; specificity

Reader study (MRMC)

sample size not stated

endpoints: AFROC Estimate; AFROC (aided-unaided); P - Value; AUC; nodule level sensitivity

Reported performance (5 observations)

sensitivity84.1CI 77.97-97.24

source quote (p.7)

“Nodule level sensitivity 84.10 (77.97-97.24)”

specificity81.09CI 76.30 – 85

source quote (p.7)

“Sensitivity of 93.83 (88.94 – 97) and specificity of 81.09 (76.30 – 85) was achieved.”

aurocas written: “auc”94.51CI 92.64 - 96.66

source quote (p.7)

“qXR-LN achieved a scan level AUC of 94.51 (92.64 - 96.66).”

sensitivityas written: “Nodule level Sensitivity (aided-unaided)”11.96

source quote (p.7)

“Nodule level Sensitivity (aided - unaided) 11.96”

aurocas written: “AUC improvement (readers)”0.0697CI 0.442 – 0.0953

source quote (p.8)

“The AUC of the readers improved by an estimate of 0.0697 (0.442 – 0.0953)”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-100%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K251934 (decision 2026-01-16) from Qure.Ai Technologies for a matching device line ("qXR-Detect") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.
first seen 2026-07-08 · k_number:K251934

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).