FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

U-SYSTEMS, INC.

The following data is part of a premarket notification filed by U-systems, Inc. with the FDA for Full Field Breast Imaging (ffbu) Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK032640
510k NumberK032640
Device Name:FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant U-SYSTEMS, INC. 2081 LONGDEN CIRCLE Los Altos,,  CA  94204
ContactSheila W Pickering
CorrespondentHeinz-joerg Steneberg
TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton,  CT  06470
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-08-27
Decision Date2003-09-11
Summary:summary

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