GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S013 · decided 2002-06-05
Approval details
- PMA number
- P990066
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2002-05-13
- Decision date
- 2002-06-05
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- ADDITION OF A SIEMENS MODEL 6GF6300-1BW04 AWS MONITOR WITH PDS CRT AS AN ALTERNATIVE SUPPLIER OF THE AWS MONITOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM AND SUPPRESSION OF THE AWS MONITOR CALIBRATION TEST.
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 |