Devices · SIEMENS MEDICAL SOLUTIONS USA, INC.

MAMMOMAT B.brilliant with Tomosynthesis Option

SIEMENS MEDICAL SOLUTIONS USA, INC. is listed for MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008). The FDA list gives September 23, 2024 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the PMA pathway. openFDA describes product code OTE as “Digital Breast Tomosynthesis”: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140011S008

Official FDA database record

Date of final decision

September 23, 2024

Company on the FDA list

SIEMENS MEDICAL SOLUTIONS USA, INC.

Lead panel

Radiology

Primary product code

OTE

openFDA device name for the code

Digital Breast Tomosynthesis

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

Not returned

Statement or summary label

Not returned