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FDA 510(k)

1717SGC_127um and 1717SGC_140um

K-Number: K171419 · 2017-06-09

ApplicantRayence Co., Ltd.
Decision Date2017-06-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1717SGC_127um and 1717SGC_140um is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2017-06-09 under approval number K171419. 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 1717SGC_127um and 1717SGC_140um?

1717SGC_127um and 1717SGC_140um is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K171419.

When was 1717SGC_127um and 1717SGC_140um approved by the FDA?

1717SGC_127um and 1717SGC_140um received FDA 510(k) clearance on 2017-06-09, under approval number K171419.

What company makes 1717SGC_127um and 1717SGC_140um?

1717SGC_127um and 1717SGC_140um is manufactured by Rayence Co., Ltd..

What is the FDA product code for 1717SGC_127um and 1717SGC_140um?

The FDA product code for 1717SGC_127um and 1717SGC_140um 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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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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