FDA 510(k)

CareView 1500P X光平面顯示器

K 號：K162178 · 2016-09-01

申請人Careray Digital Medical System Co., Ltd.

決定日期2016-09-01

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

CareView 1500P X-ray Flat Panel Detectors 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 2016-09-01 under 510(k) number K162178. 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 CareView 1500P X-ray Flat Panel Detectors?

CareView 1500P X-ray Flat Panel Detectors is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K162178.

When did CareView 1500P X-ray Flat Panel Detectors receive FDA 510(k) clearance?

CareView 1500P X-ray Flat Panel Detectors received FDA 510(k) clearance on 2016-09-01, under 510(k) number K162178.

Who is the listed applicant for CareView 1500P X-ray Flat Panel Detectors?

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 CareView 1500P X-ray Flat Panel Detectors?

The FDA product code for CareView 1500P X-ray Flat Panel Detectors 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。

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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。

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