FDA 510(k)

Nexus DR數位X光影像系統（含vSharp）

K 號：K193238 · 2019-12-20

決定日期2019-12-20

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Nexus DR Digital X-Ray Imaging System (with vSharp) is the device name listed in this FDA 510(k) record. The listed applicant is Varex Imaging Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193238. 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 Nexus DR Digital X-Ray Imaging System (with vSharp)?

Nexus DR Digital X-Ray Imaging System (with vSharp) is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Varex Imaging Corporation. The 510(k) number is K193238.

When did Nexus DR Digital X-Ray Imaging System (with vSharp) receive FDA 510(k) clearance?

Nexus DR Digital X-Ray Imaging System (with vSharp) received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193238.

Who is the listed applicant for Nexus DR Digital X-Ray Imaging System (with vSharp)?

The FDA 510(k) record lists Varex Imaging Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DR Digital X-Ray Imaging System (with vSharp)?

The FDA product code for Nexus DR Digital X-Ray Imaging System (with vSharp) is MQB.

其他以 Varex Imaging Corporation 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。

K253103Nexus DRF數位X光影像系統 K190146Nexus DR數位X光影像系統 K183212Nexus DR數位X光影像系統，配備拼貼功能 K181526XRpad2 4343 HWC-M 平板式探測器 K172951Nexus DR數位X光影像系統（配備PaxScan 4343RC及PaxScan 4343Rv3）K171138Nexus DR數位X光影像系統

查看所有 7 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。