Vivid E80, Vivid E90, Vivid E95
K-Number: K173341 · 2017-11-02
ApplicantGE Medical Systems
Decision Date2017-11-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid E80, Vivid E90, Vivid E95 is a medical device manufactured by GE Medical Systems. It received FDA 510(k) clearance on 2017-11-02 under approval number K173341. 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 Vivid E80, Vivid E90, Vivid E95?
Vivid E80, Vivid E90, Vivid E95 is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by GE Medical Systems. The 510(k) number is K173341.
When was Vivid E80, Vivid E90, Vivid E95 approved by the FDA?
Vivid E80, Vivid E90, Vivid E95 received FDA 510(k) clearance on 2017-11-02, under approval number K173341.
What company makes Vivid E80, Vivid E90, Vivid E95?
Vivid E80, Vivid E90, Vivid E95 is manufactured by GE Medical Systems.
What is the FDA product code for Vivid E80, Vivid E90, Vivid E95?
The FDA product code for Vivid E80, Vivid E90, Vivid E95 is IYN.
Other Devices by GE Medical Systems
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.