- Device
- Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option
- Applicant
- Siemens Medical Solutions USA, Inc.
- PMA number
- P140011
- Supplement
- S005
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2017-09-29
- Decision code
- APPR
- Date received
- 2017-08-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the detector, updated detector (LMAM2V2) with new electronic circuits for read-out.