FDA 510(k)

MDR17移動直接射線攝影系統

K 號：K173018 · 2017-11-20

決定日期2017-11-20

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

MDR17 Mobile Direct Radiographic System is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K173018. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MDR17 Mobile Direct Radiographic System?

MDR17 Mobile Direct Radiographic System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Del Medical, Inc.. The 510(k) number is K173018.

When did MDR17 Mobile Direct Radiographic System receive FDA 510(k) clearance?

MDR17 Mobile Direct Radiographic System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K173018.

Who is the listed applicant for MDR17 Mobile Direct Radiographic System?

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

What is the FDA product code for MDR17 Mobile Direct Radiographic System?

The FDA product code for MDR17 Mobile Direct Radiographic System is IZL.

其他以 Del Medical, Inc. 為申請人之記錄

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K223550DMX

相關器械（代碼：IZL）

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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官方來源

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