Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k) clearance K260087 · decided 2026-03-24
Clearance details
- K-number
- K260087
- Device name
- Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- Applicant
- GE Medical Systems SCS
- Decision
- Substantially Equivalent
- Date received
- 2026-01-12
- Decision date
- 2026-03-24
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- MUE
- Device class
- 2
- Regulation number
- 892.1715
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buc, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| Bellalun 2D (VDMS-1000S) (K254092) | Vieworks Co., Ltd. | 2026-05-28 |
| HESTIA (K243420) | Genoray Co., Ltd. | 2025-07-17 |
| 2430TCA with Xmaru W (K243849) | Rayence Co., Ltd. | 2025-03-12 |
| VIVIX-M (K241113) | Vieworks Co., Ltd. | 2025-01-16 |
| MAMMOMAT B.brilliant (K233539) | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| RMF-2000 (K220073) | DRTECH Corporation | 2023-01-26 |
| Planmed Clarity 2D, Planmed Clarify S (K211720) | Planmed OY | 2022-07-18 |
| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
| Digimamo D (K210151) | Vmi Tecnologias Ltda | 2022-03-01 |
| Helianthus (K202822) | Metaltronica Spa | 2021-12-15 |
| Senographe Pristina (K211725) | GE Healthcare | 2021-08-06 |
Recalls involving this device
No recalls on record reference this clearance.