FDA 510(k)

Vivid iq

Número K: K221148 · 2022-07-18

RequerenteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Data da decisão2022-07-18

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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