FDA 510(k)

智能NR

K 號：K212269 · 2021-09-17

決定日期2021-09-17

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Intelligent NR is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K212269. 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 Intelligent NR?

Intelligent NR is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Canon, Inc.. The 510(k) number is K212269.

When did Intelligent NR receive FDA 510(k) clearance?

Intelligent NR received FDA 510(k) clearance on 2021-09-17, under 510(k) number K212269.

Who is the listed applicant for Intelligent NR?

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 Intelligent NR?

The FDA product code for Intelligent NR 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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