FDA 510(k)

NOBLUS™ 超音波診断システム

K番号: K160559 · 2016-10-18

決定日2016-10-18

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

関連機器（コード：IYN）

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医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：IYN）

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