FDA 510(k)

Vivid E80, Vivid E90, Vivid E95

K-Number: K173341 · 2017-11-02

Decision Date2017-11-02

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vivid E80, Vivid E90, Vivid E95 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K173341. 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 Vivid E80, Vivid E90, Vivid E95?

Vivid E80, Vivid E90, Vivid E95 is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is GE Medical Systems. The 510(k) number is K173341.

When did Vivid E80, Vivid E90, Vivid E95 receive FDA 510(k) clearance?

Vivid E80, Vivid E90, Vivid E95 received FDA 510(k) clearance on 2017-11-02, under 510(k) number K173341.

Who is the listed applicant for Vivid E80, Vivid E90, Vivid E95?

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

What is the FDA product code for Vivid E80, Vivid E90, Vivid E95?

The FDA product code for Vivid E80, Vivid E90, Vivid E95 is IYN.

Other records listing GE Medical Systems as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.