Senographe Pristina 3D
FDA premarket approval P130020/S003 · decided 2017-12-28
Approval details
- PMA number
- P130020
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Senographe Pristina 3D
- Generic name
- Digital breast tomosynthesis
- Applicant
- GE Healthcare
- Date received
- 2017-10-26
- Decision date
- 2017-12-28
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- Approval for a change to Senographe Pristina 3D to add a new Digital Breast Tomosynthesis (DBT) Automatic Optimization of Parameters (AOP) table, called 3D STD+. This new AOP table enables the acquisition of DBT datasets at a dose equivalent to 2D STD+, already enabled on Senographe Pristina for 2D examination. As in 2D, the user will be able to choose which AOP table to use for 3D acquisitions: 3D STD or 3D STD+.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| View (K253639) | GE Healthcare | 2026-01-08 |
| MR Contour DL (K242925) | GE Healthcare | 2025-04-01 |
| Digital Expert Access with Remote Scanning (K232346) | GE Healthcare | 2023-10-27 |
| Precision DL (K223212) | GE Healthcare | 2023-04-27 |
| Xeleris V Processing and Review System (K221680) | GE Healthcare | 2023-03-01 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |
| Voluson P6, Voluson P8 (K213689) | GE Healthcare | 2022-02-17 |
| Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642) | GE Healthcare | 2022-01-13 |