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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceBREAST COMPANION SOFTWARE SYSTEM
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ALMEN LABORATORIES, INC.
1672 gil way
vista, CA 92084
PMA NumberP100007
Date Received02/17/2010
Decision Date02/10/2012
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 12M-0172
Notice Date 03/06/2012
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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