Radiology AI Directory

FDA-cleared profile

QP-Brain®

Quibim S.L.

Authorized purpose: Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and older, as a support tool for properly trained clinicians assessing structural MRIs; patient-management decisions must not rely solely on the device results.

Quantification and segmentationNeuro MRI
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and older, as a support tool for properly trained clinicians assessing structural MRIs; patient-management decisions must not rely solely on the device results.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and older, as a support tool for properly trained clinicians assessing structural MRIs; patient-management decisions must not rely solely on the device results.

Evidence takeaway

Evidence from the reviewed source record: FDA K232231 reports software verification and validation against manual expert segmentation. For T1 brain structures, Dice scores and relative-volume differences were GM 0.983 and 2.846, WM 0.990 and 1.643, CSF 0.955 and 7.495, and ICV 0.994 and 0.496. For T2 FLAIR WMH, burden-stratified Dice scores were 0.506, 0.636, 0.774, and 0.885 for low, medium, high, and very high WMH, with corresponding absolute volume errors of 0.675, 2.544, 3.097, and 7.833 mL; the packet also reports Pearson correlation of 0.88 for WMH count. No sample size or clinical-outcome study is stated in the reviewed FDA packet.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and older, as a support tool for properly trained clinicians assessing structural MRIs; patient-management decisions must not rely solely on the device results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Clinicians with proper training
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
DICOM-compatible clinical imaging workflow on off-the-shelf hardware; the FDA packet does not establish a specific facility type
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Automated structural-brain MRI segmentation, volumetric quantification, and WMH analysis with clinician review as a support tool; sequence compatibility is checked before analysis and results can be reviewed longitudinally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM-compatible MR images, including 3D T1-weighted Gradient Echo structural MRI for brain structures and T2 FLAIR MRI for WMH identification, from adults and adolescents aged 18 years and older; the application checks available sequences for compatibility before launching analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Volumes for gray matter, white matter, cerebrospinal fluid, and intracranial volume, plus WMH quantification, segmentation color overlays, morphometric reports, comparisons with age- and gender-matched normative percentile data when available, longitudinal reporting, and DICOM-formatted results displayable on DICOM workstations and PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The software is a support tool and patient-management decisions must not be based solely on its results. The FDA scope is limited to segmentable brain structures and WMH from the specified T1 and T2 FLAIR MRI inputs; WMH performance varies materially by lesion burden, and the packet does not establish a general diagnostic claim or a specific current PACS, RIS, EHR, or deployment configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K232231
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-12-13
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM-compatible input and return/display of outputs on third-party DICOM workstations and PACS are described. Exact DICOM objects, interfaces, versions, routing, and current local compatibility are not established by the FDA packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for QP-Brain®; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA K232231 reports software verification and validation against manual expert segmentation. For T1 brain structures, Dice scores and relative-volume differences were GM 0.983 and 2.846, WM 0.990 and 1.643, CSF 0.955 and 7.495, and ICV 0.994 and 0.496. For T2 FLAIR WMH, burden-stratified Dice scores were 0.506, 0.636, 0.774, and 0.885 for low, medium, high, and very high WMH, with corresponding absolute volume errors of 0.675, 2.544, 3.097, and 7.833 mL; the packet also reports Pearson correlation of 0.88 for WMH count. No sample size or clinical-outcome study is stated in the reviewed FDA packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

QP-Brain® regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232231
  • IndependenceIndependence not established

K232231

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K232231 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K232231. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K232231: QP-Brain®

    U.S. Food and Drug Administration - Published 2023-12-13 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. QP-Brain® model card (K232231)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K232231

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K232231 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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