SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S010 · decided 2001-12-03
Approval details
- PMA number
- P990066
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2001-11-16
- Decision date
- 2001-12-03
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR A MODIFIED CONTROL CONSOLE INCLUDING MINOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE APPROVED SYSTEM. THE SUPPLEMENT ALSO INCLUDES APPROPRIATE CHANGES IN THE LABELING TO REFLECT THESE CHANGES.
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