MAMMOMAT Revelation with Tomosynthesis Option
FDA premarket approval P140011/S006 · decided 2019-12-10
Approval details
- PMA number
- P140011
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAMMOMAT Revelation with Tomosynthesis Option
- Generic name
- Digital breast tomosynthesis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2019-09-12
- Decision date
- 2019-12-10
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- Approval for changes to the detector software and the tomosynthesis reconstruction pipeline.
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