K-number	K250694
Device name	Scaida BrainCT-ICH (v1.0)
Applicant	Mlhealth 360
Product code	QAS
Device class	Class II
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	892.2080

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Scaida BrainCT-ICH (v1.0)

Everything you need for a 510(k) submission. Nothing you don't.