K-number	K230552
Device name	MR DWI/FLAIR Measurement V1.0
Applicant	Olea Medical
Product code	LLZ
Device class	Class II
Decision date	Apr 26, 2023
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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MR DWI/FLAIR Measurement V1.0

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