Approval for change to the indications for use statement. The device, as modified, will be marketed under the trade name mammomat inspiration with tomosynthesis option and is indicated for acquisition of 2d as well as 3d digital mammography images to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3d dbt image set and/or a 2d ffdm image set.
Device | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION |
Classification Name | Digital Breast Tomosynthesis |
Generic Name | Digital Breast Tomosynthesis |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. |
Date Received | 2015-11-23 |
Decision Date | 2016-05-12 |
PMA | P140011 |
Supplement | S001 |
Product Code | OTE |
Advisory Committee | Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 Valley Stream Pkwy. malvern, PA 19355-1406 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P140011 | | Original Filing |
S007 |
2020-01-29 |
Normal 180 Day Track |
S006 |
2019-09-12 |
Real-time Process |
S005 |
2017-08-21 |
Real-time Process |
S004 | | |
S003 |
2016-08-26 |
Normal 180 Day Track |
S002 |
2015-12-23 |
Special (immediate Track) |
S001 |
2015-11-23 |
Normal 180 Day Track |
NIH GUDID Devices