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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2018-03-13 under 510(k) 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. The listed applicant is GE Healthcare. The 510(k) number is K180374.

When did Voluson S8/ Voluson S10/ Voluson S10 Expert receive FDA 510(k) clearance?

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

Who is the listed applicant for Voluson S8/ Voluson S10/ Voluson S10 Expert?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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