FDA 510(k)

Ox-Imager CS

K 號：K153426 · 2016-12-21

決定日期2016-12-21

產品代碼MUD

諮詢委員會履歷

決定相當於

器材摘要

Ox-Imager CS is the device name listed in this FDA 510(k) record. The listed applicant is Modulated Imaging, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K153426. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ox-Imager CS?

Ox-Imager CS is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Modulated Imaging, Inc.. The 510(k) number is K153426.

When did Ox-Imager CS receive FDA 510(k) clearance?

Ox-Imager CS received FDA 510(k) clearance on 2016-12-21, under 510(k) number K153426.

Who is the listed applicant for Ox-Imager CS?

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

What is the FDA product code for Ox-Imager CS?

The FDA product code for Ox-Imager CS is MUD.

其他以 Modulated Imaging, Inc. 為申請人之記錄

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K181623Clarifi影像系統

相關器械（代碼：MUD）

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