X-CUBE 90
K-Number: K211300 · 2021-08-09
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2021-08-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X-CUBE 90 is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2021-08-09 under approval number K211300. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the X-CUBE 90?
X-CUBE 90 is a medical device that received FDA 510(k) clearance on 2021-08-09. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K211300.
When was X-CUBE 90 approved by the FDA?
X-CUBE 90 received FDA 510(k) clearance on 2021-08-09, under approval number K211300.
What company makes X-CUBE 90?
X-CUBE 90 is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for X-CUBE 90?
The FDA product code for X-CUBE 90 is IYN.
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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.