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FDA 510(k)

YosemiteView 4343W/YosemiteView 3643W

K-Number: K232058 · 2023-08-03

ApplicantCareray Digital Medical Technology Co., Ltd.
Decision Date2023-08-03
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

YosemiteView 4343W/YosemiteView 3643W is a medical device manufactured by Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-03 under approval number K232058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K232058.

When was YosemiteView 4343W/YosemiteView 3643W approved by the FDA?

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

What company makes YosemiteView 4343W/YosemiteView 3643W?

YosemiteView 4343W/YosemiteView 3643W is manufactured by Careray Digital Medical Technology Co., Ltd..

What is the FDA product code for YosemiteView 4343W/YosemiteView 3643W?

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

Other Devices by Careray Digital Medical Technology Co., Ltd.

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

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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