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- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
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- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
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ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
- Page Type
- PMA Approval
- 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