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ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Trade Name
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
Generic Name
Digital breast tomosynthesis
Decision Date
1/10/2017
Days to Decision
162 days
Decision Code
APPR
FDA Decision
Approval

ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Trade Name
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
Generic Name
Digital breast tomosynthesis
Decision Date
1/10/2017
Days to Decision
162 days
Decision Code
APPR
FDA Decision
Approval