qCT LN Quant

K240740

Qure.ai Technologies · cleared 2024-08-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Qure.ai's computed tomography (CT) scan software, the qCT LN Quant, is a deep-learning-based device that can process non-contract CT (NCCT) scans and assists in quantitative characterization of solid lung nodules of size 6mm on Chest CTs.”

Algorithmdeep-learning-based device

source quote (p.5)

“Qure.ai's computed tomography (CT) scan software, the qCT LN Quant, is a deep-learning-based device that can process non-contract CT (NCCT) scans and assists in quantitative characterization of solid lung nodules of size 6mm on Chest CTs.”

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=104 patients

endpoints: Median Absolute Normalized Error % Short Axis Diameter; Median Absolute Normalized Error % Long Axis Diameter; Median Absolute Normalized Error % Volume

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

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

—

vs code's own 3-yr baseline

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).