|
Device | SENOGRAPHE ESSENTIAL SYSTEM |
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 | S024 |
Date Received | 08/02/2006 |
Decision Date | 09/01/2006 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD STATEMENTS TO THE USER AND INSTALLATION INSTRUCTIONS TO CAUTION ABOUT THE EQUIPMENT THAT MAY NOT PROPERLY DISPLAY OR PRINT THE LARGER IMAGES PRODUCED BY THE SENOGRAPHE ESSENTIAL. |