FDA 510(k)

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 超聲診斷系統

K 號：K202455 · 2020-12-29

決定日期2020-12-29

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2020-12-29 under 510(k) number K202455. 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 Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems is a medical device that received FDA 510(k) clearance on 2020-12-29. The listed applicant is Supersonic Imagine. The 510(k) number is K202455.

When did Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems receive FDA 510(k) clearance?

Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems received FDA 510(k) clearance on 2020-12-29, under 510(k) number K202455.

Who is the listed applicant for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

The FDA 510(k) record lists Supersonic Imagine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

The FDA product code for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems is IYN.

其他以 Supersonic Imagine 為申請人之記錄

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K242223超聲波HepaVu K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 K191007Aixplorer MACH 30, Aixplorer MACH 20 超聲診斷系統 K180572AIXPLORER MACH 超聲診斷系統 Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 K173021Aixplorer & Aixplorer Ultimate 超聲診斷系統

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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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