qER-CTA (v1.0)

K251610

Qure.ai Technologies · cleared 2025-09-08 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.11)
“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.5)
“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.”
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: AUC; Sensitivity; Specificity

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

Reported performance (6 observations)

sensitivity91.35CI 87.54%-94.07%
source quote (p.10)
“91.35% (87.54%-94.07%)”
specificity91.86CI 88.18% -94.47%
source quote (p.10)
“91.86% (88.18% -94.47%)”
aurocas written: “auc”0.959CI 0.943–0.975
source quote (p.10)
“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)”
time_to_resultas written: “SD Time to Notification”3.68
source quote (p.10)
“SD 3.68”
time_to_resultas written: “Median Time to Notification”6.89
source quote (p.10)
“Median 6.89”

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); 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/K251610