GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S009 · decided 2002-06-05
Approval details
- PMA number
- P990066
- Supplement
- S009
- Supplement type
- 135 Review Track For 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
- 2001-11-14
- Decision date
- 2002-06-05
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.
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| Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (K213642) | GE Healthcare | 2022-01-13 |