PMA P140011S009

Device: MAMMOMAT B.brilliant with Tomosynthesis Option
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S009
Product code: OTE
Decision date: 2026-07-01
Classification: Radiology
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for a manufacturing site located at Siemens Medical Solutions USA, Inc., 2501 North Barrington Rd., Hoffman Estates, IL 60192-2061.

Current openFDA PMA Record#

Device: MAMMOMAT B.brilliant with Tomosynthesis Option
Applicant: Siemens Medical Solutions USA, Inc.
PMA number: P140011
Supplement: S009
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2026-07-01
Decision code: APPR
Date received: 2025-11-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Siemens Medical Solutions USA, Inc., 2501 North Barrington Rd., Hoffman Estates, IL 60192-2061.