FDA 510(k)

AIXPLORER® & AIXPLORER® Ultimate 超聲系統

K 號：K171105 · 2017-07-11

決定日期2017-07-11

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

AIXPLORER® & AIXPLORER® Ultimate Ultrasound 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 2017-07-11 under 510(k) number K171105. 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® & AIXPLORER® Ultimate Ultrasound Systems?

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Supersonic Imagine. The 510(k) number is K171105.

When did AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems receive FDA 510(k) clearance?

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems received FDA 510(k) clearance on 2017-07-11, under 510(k) number K171105.

Who is the listed applicant for AIXPLORER® & AIXPLORER® Ultimate Ultrasound 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® & AIXPLORER® Ultimate Ultrasound Systems?

The FDA product code for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems is IYN.

其他以 Supersonic Imagine 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。

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 K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 超聲診斷系統 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

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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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