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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 K151060
Device Name Ultrasound System SONIMAGE HS1
Applicant
Konica Minolta, Inc.
1 Sakura-Machi
Hino-Shi,  JP 191-8511
Applicant Contact Shigeyuki Kojima
Correspondent
Storch Amini & Munves PC
140 E. 45th St.
25th Floor
New York,  NY  10017
Correspondent Contact Russell D Munves
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received04/20/2015
Decision Date 06/05/2015
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
Recalls CDRH Recalls
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