Fuji's Computed Radiography Mammography Suite (Fcrms)

FDA premarket approval P050014 · Full field digital, system, x-ray, mammographic

PMA numberP050014

Approval

Applicant
Fujifilm Medical System U.S.A., Inc.
Received
March 30, 2005
Decision date
July 10, 2006 (APRL)
Supplements
2, latest August 11, 2009
Product code
MUE – Full Field Digital, System, X-Ray, Mammographic

Official FDA PMA record

Approval order statement

APPROVAL FOR THE FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS). THE FCRMS IS A SOFTWARE DEVICE THAT, IN CONJUNCTION WITH A SPECIFIED FUJI COMPUTED RADIOGRAPHY SYSTEM, FORMS THE FUJI COMPUTED RADIOGRAPHY FOR MAMMOGRAPHY (FCRM) DEVICE. FCRM WITH A DEDICATED MAMMOGRAPHIC X-RAY MACHINE GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC (SFM) SYSTEMS. THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARDCOPY FILM OR SOFTCOPY DISPLAY AT A WORKSTATION.