FDA 510(k)

AXIS イメージマネジメントシステム

K番号: K171098 · 2017-05-02

決定日2017-05-02

製品コードNFJ

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

AXIS Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Sonomed, Inc.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K171098. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AXIS Image Management System?

AXIS Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Sonomed, Inc.. The 510(k) number is K171098.

When did AXIS Image Management System receive FDA 510(k) clearance?

AXIS Image Management System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K171098.

Who is the listed applicant for AXIS Image Management System?

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

What is the FDA product code for AXIS Image Management System?

The FDA product code for AXIS Image Management System is NFJ.

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AXIS イメージマネジメントシステム

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：NFJ）

公式ソース