FDA 510(k)

ACUSON NX2 Diagnostic Ultrasound Systems

K 號：K161787 · 2016-07-28

決定日期2016-07-28

產品代碼IYN

諮詢委員會RA

決定Substantially Equivalent

器材摘要

ACUSON NX2 Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161787. 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 ACUSON NX2 Diagnostic Ultrasound Systems?

ACUSON NX2 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K161787.

When did ACUSON NX2 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON NX2 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161787.

Who is the listed applicant for ACUSON NX2 Diagnostic Ultrasound Systems?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON NX2 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON NX2 Diagnostic Ultrasound Systems is IYN.

其他以 Siemens Medical Solutions USA, Inc. 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。

官方來源

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