X-CUBE 70
K-Number: K211299 · 2021-08-09
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2021-08-09
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 2021-08-09 under approval number K211299. 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 2021-08-09. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K211299.
When was X-CUBE 70 approved by the FDA?
X-CUBE 70 received FDA 510(k) clearance on 2021-08-09, under approval number K211299.
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.
Related Devices (Code: IYN)
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd.
K163138Clarius Ultrasound SystemClarius Mobile Health Corp.
K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics
K162583ALOKA LISENDO 880Hitachi , Ltd.
K163020Xperius Ultrasound SystemPhilips Health Care
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.