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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
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