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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 K180084
Device Name Ultrasound System SONIMAGE MX1
Applicant
Konica Minolta, Inc.
1 Sakura-machi
Hino-shi,  JP 191-8511
Applicant Contact Tsutomu Fukui
Correspondent
Storch Amini PC
140 East 45th Street
25th Floor
NewYork,  NY  10017
Correspondent Contact Russell D Munves
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received01/11/2018
Decision Date 02/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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