qER-CTA (v1.0)
K251610Qure.ai Technologies · cleared 2025-09-08 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“qER-CTA is a radiological computer-aided triage and notification (CADt) software designed to assist trained clinicians and radiologists in analyzing and triaging head CTA scans for suspected LVO (Large Vessel Occlusion) in the anterior circulation. The qER-CTA is a software only device with similar indications, technological characteristics, and principles of operation as the predicate devices.”
Algorithmdeep learning algorithm
source quote (p.4)
“qER-CTA uses a deep learning algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist in parallel to standard of care image interpretation. The software uses a deep learning algorithm to analyze CTA images and provide a case-level output available in the PACS or workstation for worklist prioritization or triage.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Standalone
n=584 scans
endpoints: Sensitivity; Specificity; AUC; Mean Time to Notification
standards: ISO 13485: 2016, IEC 62304:2006+A1:2015
Reported performance (4 observations)
sensitivity91.35CI 87.54%-94.07%
source quote (p.10)
“Sensitivity: 91.35% (95% CI: 87.54%-94.07%)”
specificity91.86CI 88.18% -94.47%
source quote (p.10)
“Specificity: 91.86% (95% CI: 88.18% -94.47%)”
aurocas written: “auc”0.959CI 0.943–0.975
source quote (p.10)
“AUC (95% CI) 0.959 (0.943–0.975)”
time_to_resultas written: “Mean Time to Notification”6.36CI 6.06-6.66
source quote (p.10)
“Mean 6.36 (6.06-6.66)”
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
—
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). 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).