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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 K181277
Device Name E-CUBE 12
Applicant
Alpinion Medical Systems Co., Ltd.
1fl And 6fl, Verdi Tower, 72, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08393
Applicant Contact Boyeon Cho
Correspondent
Alpinion Medical Systems Co., Ltd.
1fl And 6fl, Verdi Tower, 72, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08393
Correspondent Contact Boyeon Cho
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/14/2018
Decision Date 09/28/2018
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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