PMA P990066S008

Device
MOBILE SENOGRAPHE 2000D
Applicant
GE Healthcare
PMA number
P990066
Supplement
S008
Product code
MUE
Decision date
2001-12-18
Classification
Full Field Digital, System, X-ray, Mammographic
Generic name
Full field digital, system, x-ray, mammographic
Approval order 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.

Current openFDA PMA Record#

Device
MOBILE SENOGRAPHE 2000D
Applicant
GE Healthcare
PMA number
P990066
Supplement
S008
Product code
MUE
Generic name
Full field digital, system, x-ray, mammographic
Decision date
2001-12-18
Decision code
APPR
Date received
2001-10-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order 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.