PMA P990066S023

Device: SENOGRAPHE DS FFDM SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S023
Product code: MUE
Decision date: 2006-05-05
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL TO CORRECT A SCALE RULE ANNOTATION ON PRINTED DIGITAL MAMMOGRAPHY IMAGES AND CORRESPONDING LABELING CHANGES TO THE OPERATOR INSTRUCTIONS.

Current openFDA PMA Record#

Device: SENOGRAPHE DS FFDM SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S023
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2006-05-05
Decision code: APPR
Date received: 2006-04-17
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO CORRECT A SCALE RULE ANNOTATION ON PRINTED DIGITAL MAMMOGRAPHY IMAGES AND CORRESPONDING LABELING CHANGES TO THE OPERATOR INSTRUCTIONS.