X-CUBE 50, X-CUBE 60
K-Number: K220857 · 2022-10-13
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2022-10-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X-CUBE 50, X-CUBE 60 is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under approval number K220857. 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 50, X-CUBE 60?
X-CUBE 50, X-CUBE 60 is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K220857.
When was X-CUBE 50, X-CUBE 60 approved by the FDA?
X-CUBE 50, X-CUBE 60 received FDA 510(k) clearance on 2022-10-13, under approval number K220857.
What company makes X-CUBE 50, X-CUBE 60?
X-CUBE 50, X-CUBE 60 is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for X-CUBE 50, X-CUBE 60?
The FDA product code for X-CUBE 50, X-CUBE 60 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.