FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
FDA premarket approval P050014 · decided 2006-07-10
Approval details
- PMA number
- P050014
- Trade name
- FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Date received
- 2005-03-30
- Decision date
- 2006-07-10
- Days to decision
- 467 days
- Decision code
- APRL
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- 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) S
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