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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceBREAST COMPANION SOFTWARE SYSTEM
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantALMEN LABORATORIES, INC.
1672 GIL WAY
VISTA, CA 92084
PMA NumberP100007
Date Received02/17/2010
Decision Date02/10/2012
Withdrawal Date 09/22/2016
Product Code MYN 
Docket Number 12M-0172
Notice Date 03/06/2012
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM. THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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