FDA 510(k)

VIVIX-S 1417N

K 號：K163703 · 2017-02-08

決定日期2017-02-08

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

VIVIX-S 1417N is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K163703. 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 VIVIX-S 1417N?

VIVIX-S 1417N is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K163703.

When did VIVIX-S 1417N receive FDA 510(k) clearance?

VIVIX-S 1417N received FDA 510(k) clearance on 2017-02-08, under 510(k) number K163703.

Who is the listed applicant for VIVIX-S 1417N?

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

What is the FDA product code for VIVIX-S 1417N?

The FDA product code for VIVIX-S 1417N is MQB.

其他以 Vieworks Co., 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。

K260820VIVIX-S 4386W (FXRD-4386WA)K254092貝拉倫2D (VDMS-1000S)K251410VXvue K241113VIVIX-M K241125VIVIX-S 1751S K220239固態X光影像儀（型號：FXRD-4386WB）

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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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