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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 K142197
Device Name ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
Applicant
KONICA MINOLTA INC.
1 SAKUA-MACHI
HINO-SHI,  JP 191-8511
Applicant Contact SHIGEYUKI KOJIMA
Correspondent
STORCH AMINI & MUNVES PC
140 EAST 45TH STREET, 25TH FLOOR
NEW YORK,  NY  10017
Correspondent Contact RUSSEL D.MUNVES
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/11/2014
Decision Date 11/21/2014
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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