Vivid T8, Vivid T9
K-Number: K181934 · 2018-11-06
Decision Date2018-11-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid T8, Vivid T9 is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2018-11-06 under approval number K181934. 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 2018-11-06. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K181934.
When was Vivid T8, Vivid T9 approved by the FDA?
Vivid T8, Vivid T9 received FDA 510(k) clearance on 2018-11-06, under approval number K181934.
What company makes Vivid T8, Vivid T9?
Vivid T8, Vivid T9 is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
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 & Primary Care Diagnostics, LLC
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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.