Vivid T9/Vivid T8
K-Number: K243628 · 2025-02-11
Decision Date2025-02-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid T9/Vivid T8 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-02-11 under approval number K243628. 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 T9/Vivid T8?
Vivid T9/Vivid T8 is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K243628.
When was Vivid T9/Vivid T8 approved by the FDA?
Vivid T9/Vivid T8 received FDA 510(k) clearance on 2025-02-11, under approval number K243628.
What company makes Vivid T9/Vivid T8?
Vivid T9/Vivid T8 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vivid T9/Vivid T8?
The FDA product code for Vivid T9/Vivid T8 is IYN.
Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics
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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.