FDA 510(k)

X光平面面板檢測器/CareView 3600RF

K 號：K202995 · 2021-02-19

申請人Careray Digital Medical System Co., Ltd.

決定日期2021-02-19

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

X-ray Flat Panel Detectors/CareView 3600RF is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202995. 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 X-ray Flat Panel Detectors/CareView 3600RF?

X-ray Flat Panel Detectors/CareView 3600RF is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K202995.

When did X-ray Flat Panel Detectors/CareView 3600RF receive FDA 510(k) clearance?

X-ray Flat Panel Detectors/CareView 3600RF received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202995.

Who is the listed applicant for X-ray Flat Panel Detectors/CareView 3600RF?

The FDA 510(k) record lists Careray Digital Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-ray Flat Panel Detectors/CareView 3600RF?

The FDA product code for X-ray Flat Panel Detectors/CareView 3600RF is MQB.

其他以 Careray Digital Medical System 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。

K201932X光平面面板檢測器（CareView 1800Cwe /CareView 1500Cwe）K193173照顧視野 1800Le K172581CareView 1800Cw X光平面顯示器 K163019CareView 750Cw/750C X光平面顯示器 K162178CareView 1500P X光平面顯示器

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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