- Device
- MAMMOMAT Revelation with Tomosynthesis Option System
- Applicant
- Siemens Medical Solutions USA, Inc.
- PMA number
- P140011
- Supplement
- S007
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2020-08-21
- Decision code
- APPR
- Date received
- 2020-01-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for 1) a new processing scheme for synthetic mammograms (new Insight 2D/3D), and 2) an updated Indications for Use to include Digital Breast Tomosynthesis (DBT) in combination with synthesized image sets, Insight 2D, or Insight 2D and Insight 3D, as a screening mode, for MAMMOMAT Revelation with Tomosynthesis Option.