MAMMOMAT B.brilliant with Tomosynthesis Option
FDA premarket approval P140011/S008 · decided 2024-09-23
Approval details
- PMA number
- P140011
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAMMOMAT B.brilliant with Tomosynthesis Option
- Generic name
- Digital breast tomosynthesis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2024-02-29
- Decision date
- 2024-09-23
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- Approval for 1) new reconstruction algorithm called PREMIA, 2) updated image acquisition hardware to enable faster tomosynthesis scan, 3) rebranding the system to MAMMOMAT B.brilliant with Tomosynthesis Option.
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510(k) clearances by this applicant
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|---|---|---|
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
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| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |