FDA 510(k)

數位診斷移動X光系統

K 號：K181626 · 2018-07-20

決定日期2018-07-20

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

Digital Diagnostic Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K181626. 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 Digital Diagnostic Mobile X-ray System?

Digital Diagnostic Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K181626.

When did Digital Diagnostic Mobile X-ray System receive FDA 510(k) clearance?

Digital Diagnostic Mobile X-ray System received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181626.

Who is the listed applicant for Digital Diagnostic Mobile X-ray System?

FDA 510(k) 記錄將三星電子有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Digital Diagnostic Mobile X-ray System?

The FDA product code for Digital Diagnostic Mobile X-ray System is IZL.

其他以 Samsung Electronics Co., Ltd. 為申請人之記錄

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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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