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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 K152577
Device Name ULTRASOUND SYSTEM SONIMAGE HS 1
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/09/2015
Decision Date 10/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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