FDA 510(k)

YosemiteView 4343W/YosemiteView 3643W

Número K: K232058 · 2023-08-03

RequerenteCareray Digital Medical Technology Co., Ltd.

Data da decisão2023-08-03

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

YosemiteView 4343W/YosemiteView 3643W 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 2023-08-03 under 510(k) number K232058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the YosemiteView 4343W/YosemiteView 3643W?

YosemiteView 4343W/YosemiteView 3643W is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K232058.

When did YosemiteView 4343W/YosemiteView 3643W receive FDA 510(k) clearance?

YosemiteView 4343W/YosemiteView 3643W received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232058.

Who is the listed applicant for YosemiteView 4343W/YosemiteView 3643W?

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 YosemiteView 4343W/YosemiteView 3643W?

The FDA product code for YosemiteView 4343W/YosemiteView 3643W is MQB.

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Outros registros que listam Careray Digital Medical Technology Co., Ltd. como candidato(a)

K223687X-ray Flat Panel Detectors (EverestView 4343X)K221549X-ray Flat Panel Detectors (CareView 1800 RF)

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Fonte oficial

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