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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 K080930
Device Name MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Applicant
U-System, Inc.
110 Rose Orchard Way
San Jose,  CA  95134
Applicant Contact LISA SCOTT
Correspondent
U-System, Inc.
110 Rose Orchard Way
San Jose,  CA  95134
Correspondent Contact LISA SCOTT
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/02/2008
Decision Date 08/07/2008
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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