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FDA 510(k)

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

K-Number: K160579 · 2016-04-08

ApplicantRayence Co., Ltd.
Decision Date2016-04-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under approval number K160579. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K160579.

When was Xmaru View V1 and Xmaru PACS, Medical Image Processing Software approved by the FDA?

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software received FDA 510(k) clearance on 2016-04-08, under approval number K160579.

What company makes Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is manufactured by Rayence Co., Ltd..

What is the FDA product code for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

The FDA product code for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software is LLZ.

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Other Devices by Rayence Co., Ltd.

K1625181012WCC, 1012WGC K1625191717WCC / 1717WGC 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: LLZ)

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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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