GBrain MRI

K250416

Galileo CDS, Inc · cleared 2025-04-11 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“GBrain MRI is a non-invasive MR imaging post-processing medical device software”

AlgorithmAutomated segmentation using deep learning

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)

Standalone

sample size not stated

endpoints: volume measurement accuracy; segmentation overlap agreement

Reported performance (1 observation)

diceas written: “Dice similarity coefficient”stated without value

source quote (p.12)

“Comparisons to expert segmentations were quantified using OLS Regression, and Dice similarity coefficient (extent of software-derived vs. ground truth overlap).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K252362 (decision 2025-08-22) from Galileo CDS, Inc for a matching device line ("GBrain MRI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252362

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).