K-number	K233583
Device name	FCT iSTREAM Phase 1
Applicant	FUJIFILM Healthcare Americas Corporation
Product code	JAK
Device class	Class II
Decision date	Apr 26, 2024
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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FCT iSTREAM Phase 1

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