GBrain MRI

K252362

Galileo CDS, Inc · cleared 2025-08-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“GBrain MRI is a post processing medical device software intended for analyzing and quantitatively reporting signal hyperintensities in the brain on T2w FLAIR MR images and T1w post contrast images in the context of diagnostic radiology.”
AlgorithmAutomated segmentation using deep learning followed by volume calculations, and report generation.
source quote (p.11)
“Automated segmentation using deep learning followed by volume calculations, and report generation.”
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)

Retrospective clinical

n=131 cases · 4 site(s)

endpoints: volume measurement accuracy; segmentation overlap agreement; OLS Regression; Dice similarity coefficient

Reported performance (7 observations)

diceas written: “DICE (Contrast Enhancement)”stated without valueCI lower bound of the 95% CI for DICE was 0.81
source quote (p.14)
“while the lower bound of the 95% CI for DICE was 0.81.”
diceas written: “Median DICE (Volume < 4.2 cm3)”0.73
source quote (p.14)
“Small less than 4.2 cm3 0.73”
diceas written: “Median DICE (Volume 4.2-64.9 cm3)”0.85
source quote (p.14)
“Between 4.2-64.9 cm3 0.85”
diceas written: “Median DICE (Z-score 0-1.49)”0.69
source quote (p.14)
“0 - 1.49 0.69”
diceas written: “Median DICE (Z-score 1.5-1.99)”0.79
source quote (p.14)
“1.5 - 1.99 0.79”
diceas written: “Median DICE (Z-score 2.0-2.99)”0.81
source quote (p.14)
“2.0 - 2.99 0.81”
diceas written: “Median DICE (Z-score 3.0+)”0.87
source quote (p.14)
“3.0+ 0.87”

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/K252362