FDA 510(k)

數位X光攝影 CXDI-CS01

K 號：K222661 · 2022-09-27

決定日期2022-09-27

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Digital Radiography CXDI-CS01 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K222661. 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 Digital Radiography CXDI-CS01?

Digital Radiography CXDI-CS01 is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Canon, Inc.. The 510(k) number is K222661.

When did Digital Radiography CXDI-CS01 receive FDA 510(k) clearance?

Digital Radiography CXDI-CS01 received FDA 510(k) clearance on 2022-09-27, under 510(k) number K222661.

Who is the listed applicant for Digital Radiography CXDI-CS01?

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 Digital Radiography CXDI-CS01?

The FDA product code for Digital Radiography CXDI-CS01 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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