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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 K041947
Device Name I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
Applicant
INNOVATIVE IMAGING, INC.
9940 BUSINESS PARK DR.
SUITE 155
SACRAMENTO,  CA  95827
Applicant Contact CYNTHIA KENDALL
Correspondent
INNOVATIVE IMAGING, INC.
9940 BUSINESS PARK DR.
SUITE 155
SACRAMENTO,  CA  95827
Correspondent Contact CYNTHIA KENDALL
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/20/2004
Decision Date 08/16/2004
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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