FDA 510(k)

X射线平板探测器（CareView 1800Cwe /CareView 1500Cwe）

K号: K201932 · 2020-08-07

申请人Careray Digital Medical System Co., Ltd.

决定日期2020-08-07

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) 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 2020-08-07 under 510(k) number K201932. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Careray Digital Medical System Co., Ltd.. The 510(k) number is K201932.

When did X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) receive FDA 510(k) clearance?

X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201932.

Who is the listed applicant for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)?

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 1800Cwe /CareView 1500Cwe)?

The FDA product code for X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) is MQB.

列明Careray Digital Medical System Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K202995X射线平板探测器/护理视界3600RF K193173CareView 1800Le K172581CareView 1800Cw X射线平板探测器 K163019CareView 750Cw/750C X射线平板探测器 K162178CareView 1500P X射线平板探测器

官方来源

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