FDA 510(k)

X射线平板探测器（CareView 1800 RF）

K号: K221549 · 2022-08-01

申请人Careray Digital Medical Technology Co., Ltd.

决定日期2022-08-01

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 1800 RF) is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-01 under 510(k) number K221549. 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 1800 RF)?

X-ray Flat Panel Detectors (CareView 1800 RF) is a medical device that received FDA 510(k) clearance on 2022-08-01. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K221549.

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

X-ray Flat Panel Detectors (CareView 1800 RF) received FDA 510(k) clearance on 2022-08-01, under 510(k) number K221549.

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

The FDA 510(k) record lists Careray Digital Medical Technology 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 1800 RF)?

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

列明Careray Digital Medical Technology 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。

K232058约塞米蒂视界 4343W/约塞米蒂视界 3643W K223687X射线平板探测器（EverestView 4343X）

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