K-number	K162902
Device name	ARIETTA Prologue Diagnostic Ultrasound system and Transducers
Applicant	Hitachi , Ltd.
Product code	IYN
Device class	Class II
Decision date	Dec 15, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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ARIETTA Prologue Diagnostic Ultrasound system and Transducers

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