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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 K162065
Device Name Ultrasound System SONIMAGE HS1
Applicant
KONICA MINOLTA, INC.
1 Sakura-machi
Hino-shi,  JP 191-8511
Applicant Contact Tsutomu Fukui
Correspondent
STORCH AMINI & MUNVES PC
140 East 45th Street, 25th Floor
New York,  NY  10017
Correspondent Contact Russell D. Munves
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/26/2016
Decision Date 10/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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