|
Device | MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION |
Generic Name | Digital breast tomosynthesis |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MALVERN, PA 19355-1406 |
PMA Number | P140011 |
Supplement Number | S002 |
Date Received | 12/23/2015 |
Decision Date | 01/13/2016 |
Product Code |
OTE |
Advisory Committee |
Radiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO IMPLEMENT A SOFTWARE UPDATE THAT RESOLVES AN ERROR THAT MAY OCCUR DURING TOMOSYNTHESIS RECONSTRUCTION WITH A BREAST THICKNESS LARGER THAN 90 MM. |