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FDA 510(k)

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

K-Number: K231965 · 2023-10-30

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2023-10-30
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 2023-10-30 under approval number K231965. 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 2023-10-30. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K231965.

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 2023-10-30, under approval number K231965.

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.

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