|
Device | SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | GE Healthcare 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 |
PMA Number | P990066 |
Supplement Number | S028 |
Date Received | 02/21/2007 |
Decision Date | 04/13/2007 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR 1) A NEW COMPUTER; 2) MODIFICATION OF THE SOFTWARE; 3) ADDITION OF A THIRD PARTY SOFTWARE PROGRAM; 4) CHANGES IN THE PROPRIETARY SOFTWARE; AND 5) REPLACEMENT OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WITH A SMALLER TYPE. |