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Device | LORAD DIGITAL BREAST IMAGER |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | HOLOGIC, INC. 36 Apple Ridge Road Danbury, CT 06810 |
PMA Number | P010025 |
Date Received | 04/30/2001 |
Decision Date | 03/15/2002 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Docket Number | 02M-0173 |
Notice Date | 04/25/2002 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LORAD DIGITAL BREAST IMAGER. THE DEVICE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM MAMMOGRAPHIC SYSTEMS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S012 S013 S015 S016 S017 S018 S019 S020 |