Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

K-Number: K231467 · 2023-06-21

ApplicantRayence Co., Ltd.
Decision Date2023-06-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2023-06-21 under approval number K231467. 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 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K231467.

When was 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF approved by the FDA?

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF received FDA 510(k) clearance on 2023-06-21, under approval number K231467.

What company makes 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

The FDA product code for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-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

View all 19 devices →

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.

↑