Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S002 |
Date Received | 03/28/2003 |
Decision Date | 09/24/2003 |
Reclassified Date
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12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES IN THE SELENIA QC MANUAL: 1) CHANGE THE MINIMUM SCORES FOR THE ACR PHANTOM TEST TO 5 FIBERS, 4 SPECS, AND 4 MASSES FORM 4 FIBERS, 4 SPECS, AND 3 MASSES. 2) CHANGE THE SIGNAL-TO-NOISE TEST RESULT MINIMUM FROM 40 TO 35. THE 40 VALUE WAS BASED ON THE USE OF THE BR-12 PHANTOM, WHEREAS THE STANDARD PHANTOM IS THE ACT WITH A MINIMUM VALUE OF 35. 3) ADD A SPECIFICATION OF 28 K VP AND 65 MAS FOR PERFORMANCE OF QC TESTING. |
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