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FDA 510(k)

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)

K-Number: K242394 · 2024-09-09

ApplicantRayence Co., Ltd.
Decision Date2024-09-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2024-09-09 under approval number K242394. 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 Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) is a medical device that received FDA 510(k) clearance on 2024-09-09. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K242394.

When was Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) approved by the FDA?

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) received FDA 510(k) clearance on 2024-09-09, under approval number K242394.

What company makes Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) is manufactured by Rayence Co., Ltd..

What is the FDA product code for Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)?

The FDA product code for Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) 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.

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