FDA 510(k)

無線數位平面探測器（型號：Mars1717V-VSI，Mano4343W）

K 號：K201043 · 2020-05-12

決定日期2020-05-12

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-05-12 under 510(k) number K201043. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is a medical device that received FDA 510(k) clearance on 2020-05-12. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K201043.

When did Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) receive FDA 510(k) clearance?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) received FDA 510(k) clearance on 2020-05-12, under 510(k) number K201043.

Who is the listed applicant for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

The FDA product code for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is MQB.

其他以 Iray Technology Taicang , Ltd. 為申請人之記錄

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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相關器械（代碼：MQB）

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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