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Device | BREAST COMPANION SOFTWARE SYSTEM |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | ALMEN LABORATORIES, INC. 1672 GIL WAY VISTA, CA 92084 |
PMA Number | P100007 |
Date Received | 02/17/2010 |
Decision Date | 02/10/2012 |
Withdrawal Date
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09/22/2016 |
Product Code |
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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