PMA P050014

Device: FULL FIELD DIGITAL MAMMOGRAPHY
Applicant: Fujifilm Medical System U.S.A., Inc.
PMA number: P050014
Supplement: S002
Product code: MUE
Decision date: 2009-08-11
Classification: Radiology
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.

Current openFDA PMA Record

Device: FULL FIELD DIGITAL MAMMOGRAPHY
Applicant: Fujifilm Medical System U.S.A., Inc.
PMA number: P050014
Supplement: S002
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2009-08-11
Decision code: APPR
Date received: 2009-07-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR: 1) CHANGES IN THE CNR WEEKLY CHECK - QC TECHNOLOGIST; 2) CHANGE TO THE MONITOR QC - MEDICAL PHYSICIST TEST LUMINANCE RESPONSE TEST; 3) NEW TERMINOLOGY REGARDING USE OF THE TERM -ACQUISITION WORKSTATION; AND 4) TRADE NAME CHANGE TO ASPIRE.