Vivid S60N / Vivid S70N
K-Number: K211216 · 2021-06-09
Decision Date2021-06-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid S60N / Vivid S70N is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2021-06-09 under approval number K211216. 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 S60N / Vivid S70N?
Vivid S60N / Vivid S70N is a medical device that received FDA 510(k) clearance on 2021-06-09. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K211216.
When was Vivid S60N / Vivid S70N approved by the FDA?
Vivid S60N / Vivid S70N received FDA 510(k) clearance on 2021-06-09, under approval number K211216.
What company makes Vivid S60N / Vivid S70N?
Vivid S60N / Vivid S70N is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vivid S60N / Vivid S70N?
The FDA product code for Vivid S60N / Vivid S70N 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.