FDA 510(k)

數位X光攝影 CXDI-RF 電磁波無線設備

K 號：K232298 · 2024-04-26

決定日期2024-04-26

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K232298. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl?

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Canon, Inc.. The 510(k) number is K232298.

When did DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232298.

Who is the listed applicant for DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl?

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-RF Wireless Bl?

The FDA product code for DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl is OWB.

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)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 K222661數位X光攝影 CXDI-CS01

查看所有 24 項裝置 →

相關器械（代碼：OWB）

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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。