PMA P140011S006
- Device
- MAMMOMAT Revelation with Tomosynthesis Option
- Applicant
- Siemens Medical Solutions USA, Inc.
- PMA number
- P140011
- Supplement
- S006
- Product code
- OTE
- Decision date
- 2019-12-10
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval for changes to the detector software and the tomosynthesis reconstruction pipeline.
Current openFDA PMA Record#
- Device
- MAMMOMAT Revelation with Tomosynthesis Option
- Applicant
- Siemens Medical Solutions USA, Inc.
- PMA number
- P140011
- Supplement
- S006
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2019-12-10
- Decision code
- APPR
- Date received
- 2019-09-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the detector software and the tomosynthesis reconstruction pipeline.