QP-Brain®

K232231

Quibim S.L. · cleared 2023-12-13 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“QP-Brain® is a medical image processing and analyzing software intended for image processing to analyze brain MR imaging studies.”
AlgorithmArtificial Intelligence; automated internal pipeline that performs: artifact correction, segmentation, atlas-based parcellation, WMH quantification, volume calculation, and report generation
source quote (p.6)
“If T2 FLAIR images are uploaded, QP-Brain® uses this sequence to automatically identify white matter hyperintensities using Artificial Intelligence. Automated internal pipeline that performs: - artifact correction - segmentation - atlas-based parcellation - WMH quantification - volume calculation - report generation”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: DICE Score; Relative Volume Difference; Absolute volume error; F1 score; Pearson's correlation coefficient

Reported performance (9 observations)

diceas written: “DICE Score (GM)”0.983CI 0.981 – 0.986
source quote (p.9)
“GM 0.983 (0.981 – 0.986)”
diceas written: “DICE Score (WM)”0.99CI 0.988 – 0992
source quote (p.9)
“WM 0.990 (0.988 – 0992)”
diceas written: “DICE Score (CSF)”0.955CI 0944 – 0.965
source quote (p.9)
“CSF 0.955 (0944 – 0.965)”
diceas written: “DICE Score (ICV)”0.994CI 0.994 – 0.995
source quote (p.9)
“ICV 0.994 (0.994 – 0.995)”
diceas written: “DICE Score (Low WMH)”0.406CI 0.360 – 0.450
source quote (p.10)
“Low WMH 0.406 (0.360 -0.450)”
diceas written: “DICE Score (Medium WMH)”0.622CI 0.559 -0.699
source quote (p.10)
“Medium WMH 0.622 (0.559 -0.699)”
diceas written: “DICE Score (High WMH)”0.748CI 0.707 -0.790
source quote (p.10)
“High WMH 0.748 (0.707 -0.790)”
diceas written: “DICE Score (Very High WMH)”0.806CI 0.677 -0.923
source quote (p.10)
“Very High WMH 0.806 (0.677 -0.923)”
f1as written: “F1 score (WMH overall)”0.701CI 0.666 -0.739
source quote (p.10)
“F1 score 0.701 (0.666 -0.739)”

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/K232231