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FDA 510(k)

XmaruView V1 (Xmaru Chiroview, Xmaru Podview)

K-Number: K190866 · 2019-04-30

ApplicantRayence Co., Ltd.
Decision Date2019-04-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XmaruView V1 (Xmaru Chiroview, Xmaru Podview) 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 2019-04-30 under 510(k) number K190866. 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 XmaruView V1 (Xmaru Chiroview, Xmaru Podview)?

XmaruView V1 (Xmaru Chiroview, Xmaru Podview) is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K190866.

When did XmaruView V1 (Xmaru Chiroview, Xmaru Podview) receive FDA 510(k) clearance?

XmaruView V1 (Xmaru Chiroview, Xmaru Podview) received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190866.

Who is the listed applicant for XmaruView V1 (Xmaru Chiroview, Xmaru Podview)?

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 XmaruView V1 (Xmaru Chiroview, Xmaru Podview)?

The FDA product code for XmaruView V1 (Xmaru Chiroview, Xmaru Podview) 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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