FDA 510(k)

Vivid iq

K-Number: K161706 · 2016-08-05

ApplicantGe Medical Systems Ultrasound and Primary Care Diagnostics L

Decision Date2016-08-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vivid iq is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostics L. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K161706. 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 iq?

Vivid iq is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostics L. The 510(k) number is K161706.

When did Vivid iq receive FDA 510(k) clearance?

Vivid iq received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161706.

Who is the listed applicant for Vivid iq?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Diagnostics L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid iq?

The FDA product code for Vivid iq is IYN.

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.

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.