Voluson Performance 16; Voluson Performance 18
K-Number: K250543 · 2025-05-29
Decision Date2025-05-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Voluson Performance 16; Voluson Performance 18 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-05-29 under approval number K250543. 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 Voluson Performance 16; Voluson Performance 18?
Voluson Performance 16; Voluson Performance 18 is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K250543.
When was Voluson Performance 16; Voluson Performance 18 approved by the FDA?
Voluson Performance 16; Voluson Performance 18 received FDA 510(k) clearance on 2025-05-29, under approval number K250543.
What company makes Voluson Performance 16; Voluson Performance 18?
Voluson Performance 16; Voluson Performance 18 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Voluson Performance 16; Voluson Performance 18?
The FDA product code for Voluson Performance 16; Voluson Performance 18 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.