FDA 510(k)

無線數位平面檢測器

K 號：K183713 · 2019-01-09

決定日期2019-01-09

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Wireless Digital Flat Detector 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 2019-01-09 under 510(k) number K183713. 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 Detector?

Wireless Digital Flat Detector is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K183713.

When did Wireless Digital Flat Detector receive FDA 510(k) clearance?

Wireless Digital Flat Detector received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183713.

Who is the listed applicant for Wireless Digital Flat Detector?

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 Detector?

The FDA product code for Wireless Digital Flat Detector 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。

K223010可攜式X光系統 K222886美克魯 1717V K221714平面面板檢測器 K221345無線數位平面探測器 K220536數位平面面板檢測器 K220668無線數位平面探測器

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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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) Limited K250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

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