PMA P990066S029

Device
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
Applicant
GE Healthcare
PMA number
P990066
Supplement
S029
Product code
MUE
Decision date
2007-08-01
Classification
Full Field Digital, System, X-ray, Mammographic
Generic name
Full field digital, system, x-ray, mammographic
Approval order statement
APPROVAL FOR MODIFICATIONS OF THE GE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO PERMIT USE IN MOBILE VANS.

Current openFDA PMA Record#

Device
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL
Applicant
GE Healthcare
PMA number
P990066
Supplement
S029
Product code
MUE
Generic name
Full field digital, system, x-ray, mammographic
Decision date
2007-08-01
Decision code
APPR
Date received
2007-05-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS OF THE GE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM TO PERMIT USE IN MOBILE VANS.