ALOKA LISENDO 880
K-Number: K162583 · 2016-11-17
ApplicantHitachi , Ltd.
Decision Date2016-11-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ALOKA LISENDO 880 is a medical device manufactured by Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-11-17 under approval number K162583. 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 ALOKA LISENDO 880?
ALOKA LISENDO 880 is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Hitachi , Ltd.. The 510(k) number is K162583.
When was ALOKA LISENDO 880 approved by the FDA?
ALOKA LISENDO 880 received FDA 510(k) clearance on 2016-11-17, under approval number K162583.
What company makes ALOKA LISENDO 880?
ALOKA LISENDO 880 is manufactured by Hitachi , Ltd..
What is the FDA product code for ALOKA LISENDO 880?
The FDA product code for ALOKA LISENDO 880 is IYN.
Other Devices by Hitachi , Ltd.
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
K163020Xperius Ultrasound SystemPhilips Health Care
K161999AixplorerSupersonic Imagine
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.