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FDA 510(k)

AXIS 圖像管理系統

K 號：K171098 · 2017-05-02

申請人Sonomed, Inc.
決定日期2017-05-02
產品代碼NFJ
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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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相關器械（代碼：NFJ）

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。

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