K-number	K251527
Device name	Brain WMH
Applicant	Quantib B.V.
Product code	QIH
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Brain WMH is a medical image analysis software that automatically labels, visualizes, and quantifies white matter hyperintensities (WMH) from T2-weighted FLAIR MRI brain images. It provides segmentations, visualizations, and volumetric measurements to assist trained medical professionals in evaluating and quantitatively reporting brain MRI findings in patients 22 years or older without certain pathologies or treatment-related features.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Brain WMH

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