MAMMOMAT B.brilliant with Tomosynthesis Option is an AI-enabled medical device from SIEMENS MEDICAL SOLUTIONS USA, INC., listed by FDA (PMA supplement, P140011/S008) with a decision date of 2024-09-23. Review panel: Radiology.
| FDA submission number | P140011/S008 |
|---|---|
| Pathway | PMA supplement |
| Company | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-09-23 |
| Product code | OTE |
| Classification | Digital Breast Tomosynthesis |
| Device class | 3 |
| Review time (calendar days) | 207 |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.