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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K211299
Device Name X-CUBE 70
Applicant
Alpinion Medical Systems Co., Ltd.
5fl, I Dong, 77, Heungan-Daero 81beon-Gil Dongan-Gu
Anyang-Si,  KR 14117
Applicant Contact Boyeon Cho
Correspondent
Alpinion Medical Systems Co., Ltd.
5fl, I Dong, 77, Heungan-Daero 81beon-Gil Dongan-Gu
Anyang-Si,  KR 14117
Correspondent Contact Boyeon Cho
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/28/2021
Decision Date 08/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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