SENOCLAIRE
FDA premarket approval P130020 · decided 2014-08-26
Approval details
- PMA number
- P130020
- Trade name
- SENOCLAIRE
- Generic name
- Digital breast tomosynthesis
- Applicant
- GE Healthcare
- Date received
- 2013-07-17
- Decision date
- 2014-08-26
- Days to decision
- 405 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR THE SENOCLAIRE. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D IMAGES AND ALSO FOR THE ACQUISITION OF MULTIPLE PROJECTION VIEWS INTENDED TO PRODUCE 3D DBT IMAGES SUITABLE FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. SENOCLAIRE CAN BE USED FOR THE SAME CLINICAL APPLICATIONS AS TRADITIONAL MAMMOGRAPHY FOR SCREENING MAMMOGRAPHY. A SCREENING EXAMINATION WILL CONSIST OF:1) 2D IMAGE SET CONSISTING OF A CRANIOCAUDAL VIEW AND OF A MEDIOLATERAL OBLIQUE VIEW, OR 2) A 2D CRANIOCAUDAL VIEW
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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 |