FDA 510(k)

Vivid iq

K-Number: K221148 · 2022-07-18

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Decision Date2022-07-18

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 & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2022-07-18 under 510(k) number K221148. 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 2022-07-18. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K221148.

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

Vivid iq received FDA 510(k) clearance on 2022-07-18, under 510(k) number K221148.

Who is the listed applicant for Vivid iq?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 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.

Other records listing GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 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

View on FDA Database →

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