Radiology AI Directory

FDA-cleared profile

GBrain MRI

Galileo CDS, Inc

Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.

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

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
Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained radiologists, imaging professionals, and other clinicians working with radiological images; trained technical personnel install the software.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital, clinic, imaging center, or medical office
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing segmentation, quantification, and reporting support complementary to radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM T2w FLAIR and T1w post-contrast brain MR images from adults aged 21 and above; pediatric patients and patients after brain tumor or other resection surgery are contraindicated.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
DICOM Secondary Capture series with segmentation overlays and total hyperintensity volumes, a DICOM Encapsulated PDF report, and a DICOM SR summarizing volume measurements; outputs are intended for DICOM workstations and PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not intended for detection or specific diagnosis of disease or for detection of signal hyperintensities. It must not replace full MRI evaluation or physician decisions. Contraindicated for pediatric patients and patients who have undergone brain tumor or other resection surgery.
  • 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
K252362
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain signal hyperintensities
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-08-22
  • 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
The device accepts DICOM input and produces DICOM output that can be displayed on most third-party DICOM workstations and PACS. It is packaged as a computing appliance with DICOM file transfer, does not require a user interface after installation, and reports processing errors in output series reports or system logs; exact local interfaces are not established.
  • 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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for GBrain MRI; 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 performance testing compared software segmentations with a STAPLE consensus of three expert neuroradiologist segmentations. Contrast-enhancement validation used 131 cases from four hospital systems. The lower bound of the 95% CI for volume-measurement R2 was 0.94, the lower bound for DICE was 0.81, and reproducibility testing showed R2 of 0.92; the packet also reports size- and brightness-stratified R2/median-DICE results.
  • 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.

GBrain MRI regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K252362
  • Samplen=131
  • Sites4
  • IndependenceIndependence not established

K252362

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 K252362 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 K252362. 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
2026-09-08Last searched
23Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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 K252362: GBrain MRI

    U.S. Food and Drug Administration - Published 2025-08-22 - 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. GBrain MRI model card (K252362)

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

    Scope: intendedUsers, careSetting, output, limitations, 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 K252362

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

    Scope: postmarketSafety

Research history

  1. K252362 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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