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FDA 510(k)

Voluson S8/ Voluson S10/ Voluson S10 Expert

K-Number: K180374 · 2018-03-13

ApplicantGE Healthcare
Decision Date2018-03-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Voluson S8/ Voluson S10/ Voluson S10 Expert is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-03-13 under approval number K180374. 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 S8/ Voluson S10/ Voluson S10 Expert?

Voluson S8/ Voluson S10/ Voluson S10 Expert is a medical device that received FDA 510(k) clearance on 2018-03-13. It is manufactured by GE Healthcare. The 510(k) number is K180374.

When was Voluson S8/ Voluson S10/ Voluson S10 Expert approved by the FDA?

Voluson S8/ Voluson S10/ Voluson S10 Expert received FDA 510(k) clearance on 2018-03-13, under approval number K180374.

What company makes Voluson S8/ Voluson S10/ Voluson S10 Expert?

Voluson S8/ Voluson S10/ Voluson S10 Expert is manufactured by GE Healthcare.

What is the FDA product code for Voluson S8/ Voluson S10/ Voluson S10 Expert?

The FDA product code for Voluson S8/ Voluson S10/ Voluson S10 Expert 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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