qER-Quant

K211222

Qure.ai Technologies · cleared 2021-07-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“qER-Quant is a standalone software device that processes non-contrast head CT scans to outline and quantify the structures described in the intended use.”

Algorithmdeep learning (supervised voxel classification with Convolutional Neural Networks)

source quote (p.7)

“Segmentation by deep learning (supervised voxel classification with Convolutional Neural Networks)”

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=210 scans

endpoints: Accuracy; Segmentation Accuracy; Reproducibility

Reported performance (3 observations)

diceas written: “Dice Score (Intracranial Hyperdensity)”0.75CI 0.72 - 0.78

source quote (p.8)

“0.75 (0.72 - 0.78)”

diceas written: “Dice Score (Left Lateral Ventricle)”0.79CI 0.78 - 0.81

source quote (p.9)

“0.79 (0.78 - 0.81)”

diceas written: “Dice Score (Right Lateral Ventricle)”0.75CI 0.73 - 0.77

source quote (p.9)

“0.75 (0.73 - 0.77)”

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).