PMA P140011S008

Device: MAMMOMAT B.brilliant with Tomosynthesis Option
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S008
Product code: OTE
Decision date: 2024-09-23
Classification: Radiology
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for 1) new reconstruction algorithm called PREMIA, 2) updated image acquisition hardware to enable faster tomosynthesis scan, 3) rebranding the system to MAMMOMAT B.brilliant with Tomosynthesis Option.

Current openFDA PMA Record#

Device: MAMMOMAT B.brilliant with Tomosynthesis Option
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S008
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2024-09-23
Decision code: APPR
Date received: 2024-02-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) new reconstruction algorithm called PREMIA, 2) updated image acquisition hardware to enable faster tomosynthesis scan, 3) rebranding the system to MAMMOMAT B.brilliant with Tomosynthesis Option.