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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 K113359
Model 1VIS 20/IVIS 30/I3/Q1/Q2/Q3/Q5,D3C60L,D5C20L,V4C40L,D440L,D6C15L,D3C20L,D7L40L,D7L60L,D730L,D6C12L,D7C10L
Device Name CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
Original Applicant
CHISON MEDICAL IMAGING CO., LTD.
7263 cronin circle
dublin,  CA  94568
Original Contact bob leiker
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/14/2011
Decision Date 02/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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