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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 Echo, Ultrasonic
510(k) Number K121888
Device Name E-CUBE 15
Applicant
Alpinion Medical Systems Co., Ltd.
1, 6 And 7fl, Verdi Tower
72, Digital-Ro(St) 26-Gil(Rd) Guro-Gu
Seoul,  KR 152-848
Applicant Contact DONGHWAN KIM
Correspondent
Alpinion Medical Systems Co., Ltd.
1, 6 And 7fl, Verdi Tower
72, Digital-Ro(St) 26-Gil(Rd) Guro-Gu
Seoul,  KR 152-848
Correspondent Contact DONGHWAN KIM
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received06/28/2012
Decision Date 07/26/2012
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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