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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
Generic NameAutomated breast ultrasound
ApplicantU-SYSTEMS, INC.
9900 WEST INNOVATIVE DRIVE
MAIL STOP RP2138
WAUWATOSA, WI 53226
PMA NumberP110006
Supplement NumberS004
Date Received11/03/2014
Decision Date11/24/2014
Product Code PAA 
Advisory Committee Radiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF A CHANGE IN THE DEVICE DESIGN TO ACCOMMODATE A NEW DEVICE CONFIGURATION. THE NEW DEVICE CONFIGURATION CONSISTS OF THE FOLLOWING COMPONENTS: INVENIA ABUS SCAN STATION, INVENIA ABUS REVIEW SOFTWARE, AND USER COMPUTER/ WORK STATION THAT IS QUALIFIED TO MEET A REQUIRED SET OF HARDWARE AND SOFTWARE SPECIFICATION. IN ADDITION TO THE PROPOSED ADDITIONAL DEVICE CONFIGURATION, YOUR SUPPLEMENT REQUESTED APPROVAL OF MINOR SOFTWARE UPDATES TO ADDRESS ISSUES DISCOVERED THROUGH INTERNAL TESTING AND CUSTOMER FEEDBACK. THESE CHANGES INCLUDE MARKER POSITIONING ON IMAGES, DICOM-RELATED IMAGE CONTENT, AND GENERAL IMAGE FORMATTING, PROCESSING, AND TRANSFER. YOUR SUPPLEMENT ALSO REQUESTED LABELING CHANGES ASSOCIATED WITH THE ABOVE-SPECIFIED DEVICE CHANGE, SPECIFICALLY IN WORKSTATION USER MANUAL, SYSTEM SETUP AND BASIC SERVICE MANUAL, AND SCAN STATION MANUAL.
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