FDA 510(k)

1717FCC

K-Number: K210985 · 2021-04-28

Decision Date2021-04-28

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1717FCC is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-04-28 under approval number K210985. 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 1717FCC?

1717FCC is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K210985.

When was 1717FCC approved by the FDA?

1717FCC received FDA 510(k) clearance on 2021-04-28, under approval number K210985.

What company makes 1717FCC?

1717FCC is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1717FCC?

The FDA product code for 1717FCC is MQB.

Other Devices by Rayence Co., Ltd.

K1625181012WCC, 1012WGC K1625191717WCC / 1717WGC K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing Software K1714171417WGC_127um and 1417WGC_140um K1714181417WCC_127um and1417WCC_140um K1714201717SCC_127um and 1717SCC_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

View on FDA Database →

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