|
Device | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
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 |
Supplement Number | S003 |
Date Received | 04/15/2003 |
Decision Date | 10/10/2003 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING USER ENHANCEMENTS AND COMPONENTS; AN ADDITIONAL PERIPHERAL CONTRAST ENHANCEMENT (PCE) BASED IMAGE PROCESSING MECHANISM; THE ADDITION OF A HIGH RESOLUTION FUJI FM-DP L IMAGE PRINTER; AND UPDATED LABELING CHANGES FOR THE SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (FFDM). |