QP-Brain®
K232231Quibim 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. These brain MR images, when interpreted by clinicians with proper training, may yield clinically useful information. ... Software as a Medical Device, DICOM compatible and operate on off-the-self hardware (multiple vendors).”
AlgorithmArtificial Intelligence
source quote (p.6)
“If T2 FLAIR images are uploaded, QP-Brain® uses this sequence to automatically identify white matter hyperintensities using Artificial Intelligence.”
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
sample size not stated
endpoints: DICE Score; Relative Volume Difference; Absolute volume error; F1 score; Pearson's correlation coefficient
standards: FDA recognized consensus standards for software development
Reported performance (9 observations)
diceas written: “DICE Score (GM)”0.983CI 0.981 – 0.986
source quote (p.9)
“Table 2: Summary of the performance testing for QP-Brain® Brain volumetry analysis module. Region GM DICE Score 0.983 (0.981 – 0.986)”
diceas written: “DICE Score (WM)”0.99CI 0.988 – 0992
source quote (p.9)
“Table 2: Summary of the performance testing for QP-Brain® Brain volumetry analysis module. Region WM DICE Score 0.990 (0.988 – 0992)”
diceas written: “DICE Score (CSF)”0.955CI 0944 – 0.965
source quote (p.9)
“Table 2: Summary of the performance testing for QP-Brain® Brain volumetry analysis module. Region CSF DICE Score 0.955 (0944 – 0.965)”
diceas written: “DICE Score (ICV)”0.994CI 0.994 – 0.995
source quote (p.9)
“Table 2: Summary of the performance testing for QP-Brain® Brain volumetry analysis module. Region ICV DICE Score 0.994 (0.994 – 0.995)”
diceas written: “DICE Score (Low WMH)”0.406CI 0.360 -0.450
source quote (p.10)
“Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals). Size Low WMH DICE Score 0.406 (0.360 -0.450)”
diceas written: “DICE Score (Medium WMH)”0.622CI 0.559 -0.699
source quote (p.10)
“Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals). Size Medium WMH DICE Score 0.622 (0.559 -0.699)”
diceas written: “DICE Score (High WMH)”0.748CI 0.707 -0.790
source quote (p.10)
“Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals). Size High WMH DICE Score 0.748 (0.707 -0.790)”
f1as written: “F1 score (High WMH)”0.701CI 0.666 -0.739
source quote (p.10)
“Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals). Size High WMH F1 score 0.701 (0.666 -0.739)”
diceas written: “DICE Score (Very High WMH)”0.806CI 0.677 -0.923
source quote (p.10)
“Table 4: Summary of the performance testing for QP-Brain® Brain WMH analysis module (confidence intervals). Size Very High WMH DICE Score 0.806 (0.677 -0.923)”
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). 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).