FDA 510(k)

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K 號：K242168 · 2024-12-20

申請人GE Medical Systems Ultrasound and Primary Care Diagnostics

決定日期2024-12-20

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242168. 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 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K242168.

When did Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 receive FDA 510(k) clearance?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242168.

Who is the listed applicant for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

FDA 510(k) 記錄將GE醫療系統超聲波和基礎醫療診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

The FDA product code for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is IYN.

其他以 GE Medical Systems Ultrasound and Primary Care Diagnostics 為申請人之記錄

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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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。

官方來源

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