SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S016 · decided 2004-02-19
Approval details
- PMA number
- P990066
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2003-09-02
- Decision date
- 2004-02-19
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR CHANGES IN ERGONOMICS, THE IMAGE ACQUISITION CHAIN, IMAGE PRESENTATION ON THE AWS, AND CONNECTIVITY. IN ADDITION THE APPLICATION REQUESTED ADDITIONAL IMAGE QUALITY CLAIMS AND QC MANUAL CHANGES FOR QC TEST TECHNIQUE FACTORS AND PROCEDURES UNDER MQSA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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