GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
FDA premarket approval P990066/S029 · decided 2007-08-01
Approval details
- PMA number
- P990066
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2007-05-21
- Decision date
- 2007-08-01
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR MODIFICATIONS OF THE GE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO PERMIT USE IN MOBILE VANS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |