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 that aids in the volumetric quantification of hyperintensities in T2-weighted Fluid Attenuated Inversion Recovery (T2w FLAIR) brain MR images.”
Algorithmdeep learning to segment hyperintensities in FLAIR MR images, and subsequently calculate the volumes of these regions.
source quote (p.12)
“All the devices use deep learning to segment hyperintensities in FLAIR MR images, and subsequently calculate the volumes of these regions.”
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); 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/K250416