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FDA 510(k)

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K-Number: K242168 · 2024-12-20

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2024-12-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-12-20 under approval number K242168. 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 18; Voluson Expert 20; Voluson Expert 22?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K242168.

When was Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 approved by the FDA?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 received FDA 510(k) clearance on 2024-12-20, under approval number K242168.

What company makes Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

The FDA product code for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 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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