FDA 510(k)

Vivid T8

K-Number: K160078 · 2016-03-10

ApplicantGe Medical Systems Ultrasound and Primary Care Diagnotics, L

Decision Date2016-03-10

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vivid T8 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnotics, L. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K160078. 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 T8?

Vivid T8 is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnotics, L. The 510(k) number is K160078.

When did Vivid T8 receive FDA 510(k) clearance?

Vivid T8 received FDA 510(k) clearance on 2016-03-10, under 510(k) number K160078.

Who is the listed applicant for Vivid T8?

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

What is the FDA product code for Vivid T8?

The FDA product code for Vivid T8 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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