FDA 510(k)

1717WCC / 1717WGC

K-Number: K162519 · 2016-10-06

Decision Date2016-10-06

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1717WCC / 1717WGC is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2016-10-06 under approval number K162519. 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 1717WCC / 1717WGC?

1717WCC / 1717WGC is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K162519.

When was 1717WCC / 1717WGC approved by the FDA?

1717WCC / 1717WGC received FDA 510(k) clearance on 2016-10-06, under approval number K162519.

What company makes 1717WCC / 1717WGC?

1717WCC / 1717WGC is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1717WCC / 1717WGC?

The FDA product code for 1717WCC / 1717WGC is MQB.

Other Devices by Rayence Co., Ltd.

K1625181012WCC, 1012WGC K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing Software K1714171417WGC_127um and 1417WGC_140um K1714181417WCC_127um and1417WCC_140um K1714201717SCC_127um and 1717SCC_140um K1714191717SGC_127um and 1717SGC_140um

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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

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