qXR-Detect

K251934

Qure.Ai Technologies · cleared 2026-01-16 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“qXR-Detect is a computer-assisted detection (CADe) software device that analyzes chest radiographs and highlights suspicious regions of interest (ROIs).”
AlgorithmDeep Learning
source quote (p.7)
“Machine Learning Methodology Deep Learning”
Adaptive (vs locked)No
source quote (p.11)
“The algorithm modifications will not include any adaptive algorithms that get continuously learn from the environment.”
PCCPYes
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.7)
“Privacy HIPAA Compliant”

Validation studies (2)

Standalone

sample size not stated

endpoints: assess the device's performance against the ground truth

standards: ISO 13485: 2016, IEC 62304:2006+A1:2015

Reader study (MRMC)

n=301 cases

endpoints: determine the improvement in readers' detection and localization performance in identifying scans with suspicious chest ROIs in the 6 categories

Reported performance (4 observations)

sensitivity0.9338CI 0.9096-0.9579
source quote (p.10)
“Sensitivity with 95% CI - Aided 0.9338 (0.9096-0.9579)”
specificity0.6219CI 0.5065-0.7373
source quote (p.10)
“Specificity with 95% CI - Aided 0.6219 (0.5065-0.7373)”
aurocas written: “auc”0.872CI 0.8339-0.9100
source quote (p.10)
“AUROC with 95% CI - Aided 0.8720 (0.8339-0.9100)”
false_positive_rate_per_imageas written: “False positives per image (aided)”0.33CI 0.3149 – 0.3457
source quote (p.10)
“The number of false positives per image reduced from 0.4182 (0.4012 – 0.4358) in the reads unaided – to 0.3300 (0.3149 – 0.3457) in the reads aided by qXR-Detect.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251934