Vivid Pioneer
K-Number: K251169 · 2025-07-10
Decision Date2025-07-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vivid Pioneer is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-07-10 under approval number K251169. 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 Pioneer?
Vivid Pioneer is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251169.
When was Vivid Pioneer approved by the FDA?
Vivid Pioneer received FDA 510(k) clearance on 2025-07-10, under approval number K251169.
What company makes Vivid Pioneer?
Vivid Pioneer is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Vivid Pioneer?
The FDA product code for Vivid Pioneer 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.