FDA 510(k)

NOBLUS™ 超聲診斷系統

K 號：K160559 · 2016-10-18

決定日期2016-10-18

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

NOBLUS™ Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corporation. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K160559. 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 NOBLUS™ Ultrasound Diagnostic System?

NOBLUS™ Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Hitachi Medical Corporation. The 510(k) number is K160559.

When did NOBLUS™ Ultrasound Diagnostic System receive FDA 510(k) clearance?

NOBLUS™ Ultrasound Diagnostic System received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160559.

Who is the listed applicant for NOBLUS™ Ultrasound Diagnostic System?

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

What is the FDA product code for NOBLUS™ Ultrasound Diagnostic System?

The FDA product code for NOBLUS™ Ultrasound Diagnostic System is IYN.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源