PMA P990066S009

Device: GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S009
Product code: MUE
Decision date: 2002-06-05
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.

Current openFDA PMA Record#

Device: GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S009
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2002-06-05
Decision code: APPR
Date received: 2001-11-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF GRME AS AN ALTERNATIVE SUPPLIER OF THE GENERATOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM.