PMA P990066S024

Device: SENOGRAPHE ESSENTIAL SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S024
Product code: MUE
Decision date: 2006-09-01
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL TO ADD STATEMENTS TO THE USER AND INSTALLATION INSTRUCTIONS TO CAUTION ABOUT THE EQUIPMENT THAT MAY NOT PROPERLY DISPLAY OR PRINT THE LARGER IMAGES PRODUCED BY THE SENOGRAPHE ESSENTIAL.

Current openFDA PMA Record#

Device: SENOGRAPHE ESSENTIAL SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S024
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2006-09-01
Decision code: APPR
Date received: 2006-08-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO ADD STATEMENTS TO THE USER AND INSTALLATION INSTRUCTIONS TO CAUTION ABOUT THE EQUIPMENT THAT MAY NOT PROPERLY DISPLAY OR PRINT THE LARGER IMAGES PRODUCED BY THE SENOGRAPHE ESSENTIAL.