FDA 510(k)

固態X光影像儀（型號：FXRD-4386WB）

K 號：K220239 · 2022-09-13

決定日期2022-09-13

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Solid State X-ray Imager(Model: FXRD-4386WB) 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 2022-09-13 under 510(k) number K220239. 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 Solid State X-ray Imager(Model: FXRD-4386WB)?

Solid State X-ray Imager(Model: FXRD-4386WB) is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K220239.

When did Solid State X-ray Imager(Model: FXRD-4386WB) receive FDA 510(k) clearance?

Solid State X-ray Imager(Model: FXRD-4386WB) received FDA 510(k) clearance on 2022-09-13, under 510(k) number K220239.

Who is the listed applicant for Solid State X-ray Imager(Model: FXRD-4386WB)?

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 Solid State X-ray Imager(Model: FXRD-4386WB)?

The FDA product code for Solid State X-ray Imager(Model: FXRD-4386WB) 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 K221512Vivix-S FW (型號：FXRD-2530FAW、FXRD-3643FAW、FXRD-4343FAW)

查看所有 14 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。