FDA 510(k)

強化功能軟體包 CXDI 系列

K 號：K190368 · 2019-03-13

決定日期2019-03-13

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Enhanced Feature Software Pack CXDI Series is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K190368. 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 Enhanced Feature Software Pack CXDI Series?

Enhanced Feature Software Pack CXDI Series is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Canon, Inc.. The 510(k) number is K190368.

When did Enhanced Feature Software Pack CXDI Series receive FDA 510(k) clearance?

Enhanced Feature Software Pack CXDI Series received FDA 510(k) clearance on 2019-03-13, under 510(k) number K190368.

Who is the listed applicant for Enhanced Feature Software Pack CXDI Series?

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

What is the FDA product code for Enhanced Feature Software Pack CXDI Series?

The FDA product code for Enhanced Feature Software Pack CXDI Series is MQB.

其他以 Canon, Inc. 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。

K252503智能NR K241049佳能眼底攝影機 CR-10 (CR-10)K232298數位X光攝影 CXDI-RF 電磁波無線設備 K230175數位X光攝影 CXDI-CS01 K222855數位X光攝影 CXDI-Pro，數位X光攝影 D1 K222687數位X光攝影 CXDI-Elite，數位X光攝影 E1

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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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