X-Cube 70
K-Number: K200450 · 2020-07-10
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2020-07-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X-Cube 70 is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2020-07-10 under approval number K200450. 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 70?
X-Cube 70 is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K200450.
When was X-Cube 70 approved by the FDA?
X-Cube 70 received FDA 510(k) clearance on 2020-07-10, under approval number K200450.
What company makes X-Cube 70?
X-Cube 70 is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for X-Cube 70?
The FDA product code for X-Cube 70 is IYN.
Other Devices by Alpinion Medical Systems 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.