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.”
Algorithmpre-trained convolutional neural networks (CNNs)
source quote (p.5)
“The analysis module of the qER-Quant software contains of a set of pre-trained convolutional neural networks (CNNs), that form the core processing component shown in Figure 1.”
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)

Retrospective clinical

n=210 scans

endpoints: Volume or shift measurement accuracy; segmentation accuracy; Reproducibility testing

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

0
recalls in product code, 24mo
3
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/K211222