MOBILE SENOGRAPHE 2000D
FDA premarket approval P990066/S008 · decided 2001-12-18
Approval details
- PMA number
- P990066
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOBILE SENOGRAPHE 2000D
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2001-10-26
- Decision date
- 2001-12-18
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL TO MAKE A MOBILE VERSION OF THE DEVICE, THAT IS CAPABLE OF MOVING FROM PLACE TO PLACE IN AN AIR-RIDE VAN AND ABLE TO TRANSMIT IMAGES FROM THESE LOCATIONS VIA A WIRELESS COMMUNICATIONS LINK.
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