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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 K112022
Device Name DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Applicant
Advanced Instrumentations, Inc.
601 W. 20 St.
Hialeah,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
Advanced Instrumentations, Inc.
601 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/15/2011
Decision Date 09/22/2011
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
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