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FULL FIELD DIGITAL MAMMOGRAPHY

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Trade Name
FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
Generic Name
Full field digital, system, x-ray, mammographic
Decision Date
7/10/2006
Days to Decision
467 days
Decision Code
APRL
FDA Decision
Reclassification after approval

FULL FIELD DIGITAL MAMMOGRAPHY

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Trade Name
FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
Generic Name
Full field digital, system, x-ray, mammographic
Decision Date
7/10/2006
Days to Decision
467 days
Decision Code
APRL
FDA Decision
Reclassification after approval