Senographe Pristina 3D
FDA premarket approval P130020/S005 · decided 2025-11-21
Approval details
- PMA number
- P130020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senographe Pristina 3D
- Generic name
- Digital breast tomosynthesis
- Applicant
- GE Healthcare
- Date received
- 2025-04-21
- Decision date
- 2025-11-21
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- Approval for Senographe Pristina 3D that includes an update to the DBT reconstruction algorithm to enhance image quality using deep learning algorithms to correct sparse view artifacts, compensate for patient motion artifacts and enhance the visibility of soft tissue lesions within the 2D synthetic image.
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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 |