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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 K103608
Device Name I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
Applicant
Ellex, Inc.
9940 Business Park Dr.
Suite 165
Sacramento,  CA  95827
Applicant Contact JONATHAN STRAWN
Correspondent
Ellex, Inc.
9940 Business Park Dr.
Suite 165
Sacramento,  CA  95827
Correspondent Contact JONATHAN STRAWN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/09/2010
Decision Date 12/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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