ARIETTA 750
K-Number: K191233 · 2019-08-09
ApplicantHitachi Healthcare Americas
Decision Date2019-08-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ARIETTA 750 is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-08-09 under approval number K191233. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIETTA 750?
ARIETTA 750 is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K191233.
When was ARIETTA 750 approved by the FDA?
ARIETTA 750 received FDA 510(k) clearance on 2019-08-09, under approval number K191233.
What company makes ARIETTA 750?
ARIETTA 750 is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for ARIETTA 750?
The FDA product code for ARIETTA 750 is IYN.
Other Devices by Hitachi Healthcare Americas
Related Devices (Code: IYN)
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd.
K163138Clarius Ultrasound SystemClarius Mobile Health Corp.
K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics
K162583ALOKA LISENDO 880Hitachi , Ltd.
K163020Xperius Ultrasound SystemPhilips Health Care
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.