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 a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2019-04-30 under approval 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. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K190866.
When was XmaruView V1 (Xmaru Chiroview, Xmaru Podview) approved by the FDA?
XmaruView V1 (Xmaru Chiroview, Xmaru Podview) received FDA 510(k) clearance on 2019-04-30, under approval number K190866.
What company makes XmaruView V1 (Xmaru Chiroview, Xmaru Podview)?
XmaruView V1 (Xmaru Chiroview, Xmaru Podview) is manufactured by Rayence Co., Ltd..
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.
Other Devices by Rayence Co., Ltd.
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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.