Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K-Number: K220358 · 2022-06-06
Decision Date2022-06-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2022-06-06 under approval number K220358. 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 Expert 22, Voluson Expert 20, Voluson Expert 18?
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 is a medical device that received FDA 510(k) clearance on 2022-06-06. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K220358.
When was Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 approved by the FDA?
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 received FDA 510(k) clearance on 2022-06-06, under approval number K220358.
What company makes Voluson Expert 22, Voluson Expert 20, Voluson Expert 18?
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.
What is the FDA product code for Voluson Expert 22, Voluson Expert 20, Voluson Expert 18?
The FDA product code for Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 is IYN.
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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.