FDA-cleared profile
Galileo CDS, Inc
GBrain MRI is a post processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on FLAIR MR images in the context of diagnostic radiology. GBrain MRI is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. It is not intended for detection or specific diagnosis of any disease nor for the detection of signal hyperintensities. GBrain MRI should not be used in-lieu of a full evaluation of the patient's MRI scans. The physician retains the ultimate responsibility for making the final patient management and treatment decisions.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
Intended-user text reported in the exact-submission ACR model card.
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
Conservative normalization of explicit wording in an exact-submission source.
Conservative normalization of explicit wording in an exact-submission source.
Clinical output reported in the exact-submission ACR model card.
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Imaging modality reported in the exact-submission ACR AI Central model card.
Anatomy normalized from explicit exact-submission ACR model-card wording.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
This field has not been curated yet.
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.
Stand-Alone Performance · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K250416 · Independence not establishedK250416
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. 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, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-02.
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