FDA 510(k)

Vivid iq

K 號：K221148 · 2022-07-18

申請人GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

決定日期2022-07-18

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 為申請人之記錄

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相關器械（代碼：IYN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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