FDA 510(k)

DX-D影像包

K 號：K172784 · 2017-10-13

決定日期2017-10-13

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

DX-D Imaging Package is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K172784. 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 DX-D Imaging Package?

DX-D Imaging Package is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K172784.

When did DX-D Imaging Package receive FDA 510(k) clearance?

DX-D Imaging Package received FDA 510(k) clearance on 2017-10-13, under 510(k) number K172784.

Who is the listed applicant for DX-D Imaging Package?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DX-D Imaging Package?

The FDA product code for DX-D Imaging Package is MQB.

其他以 Agfa Healthcare N.V. 為申請人之記錄

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K252199AGFA HealthCare Enterprise Imaging K180589DR 800 配合 MUSICA 運動 K170434企業影像 XERO 觀察器 8.1 K161368DX-D影像包（DR 10s）、DX-D影像包（DR 14s）、DX-D影像包（DR 14s）K161061輸出體積檢視 4.0

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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