Vivid T8, Vivid T9
K-Number: K200851 · 2020-09-09
Decision Date2020-09-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid T8, Vivid T9 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-09-09 under approval number K200851. 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 T8, Vivid T9?
Vivid T8, Vivid T9 is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K200851.
When was Vivid T8, Vivid T9 approved by the FDA?
Vivid T8, Vivid T9 received FDA 510(k) clearance on 2020-09-09, under approval number K200851.
What company makes Vivid T8, Vivid T9?
Vivid T8, Vivid T9 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vivid T8, Vivid T9?
The FDA product code for Vivid T8, Vivid T9 is IYN.
Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics
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.