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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
Recalls CDRH Recalls
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