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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 the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) 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. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K160579.

When did Xmaru View V1 and Xmaru PACS, Medical Image Processing Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Xmaru View V1 and Xmaru PACS, Medical Image Processing Software?

The FDA 510(k) record lists Rayence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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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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