PMA P990066S002

Device
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
GE Healthcare
PMA number
P990066
Supplement
S002
Product code
MUE
Decision date
2001-01-08
Classification
Full Field Digital, System, X-ray, Mammographic
Generic name
Full field digital, system, x-ray, mammographic
Approval order statement
APPROVAL FOR THE KODAK DRYVIEW 8610 PRINTER FOR USE WITH THE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.

Current openFDA PMA Record#

Device
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
GE Healthcare
PMA number
P990066
Supplement
S002
Product code
MUE
Generic name
Full field digital, system, x-ray, mammographic
Decision date
2001-01-08
Decision code
APPR
Date received
2000-12-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE KODAK DRYVIEW 8610 PRINTER FOR USE WITH THE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.