Vivid iq
K-Number: K161706 · 2016-08-05
Decision Date2016-08-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid iq is a medical device manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostics L. It received FDA 510(k) clearance on 2016-08-05 under approval number K161706. 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 iq?
Vivid iq is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostics L. The 510(k) number is K161706.
When was Vivid iq approved by the FDA?
Vivid iq received FDA 510(k) clearance on 2016-08-05, under approval number K161706.
What company makes Vivid iq?
Vivid iq is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostics L.
What is the FDA product code for Vivid iq?
The FDA product code for Vivid iq is IYN.
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.