PMA P140011S003

Device: MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S003
Product code: OTE
Decision date: 2017-03-23
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order statement: The device, as modified, will be marketed under the trade name Mammomat Inspiration With Tomosynthesis Option and is indicated for use with the EMPIRE reconstruction algorithm for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer.A screening exam may consist of a:- 2D image set.- 3D DBT image set and a 2D FFDM image set or a- 3D DBT image set alone.

Current openFDA PMA Record#

Device: MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S003
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2017-03-23
Decision code: APPR
Date received: 2016-08-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: The device, as modified, will be marketed under the trade name Mammomat Inspiration With Tomosynthesis Option and is indicated for use with the EMPIRE reconstruction algorithm for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer.A screening exam may consist of a:- 2D image set.- 3D DBT image set and a 2D FFDM image set or a- 3D DBT image set alone.