Advisory Committees
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2009 Meeting Materials of the Radiological Devices Panel
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November 17, 2009 Meeting Materials-- FDA Generated
Agenda (PDF - 50KB)Panel Questions (PDF - 16KB)Public Roster November 17 (PDF - 10KB)Attachment 1 FFDM Draft Panel Questions (PDF - 15KB)Attachment 2 FFDM Draft Guidance (PDF - 208KB)Attachment 3 FFDM PMA Guidance (PDF - 165KB)Attachment 4 Summary Minutes (PDF - 59KB)Attachment 11 FFDM Panel Transcript (PDF - 595KB)FFDM 24 Hour Summary (PDF - 70KB)Transcript (PDF - 1018KB)Executive Summary (DOC - 208KB)Gwise Presentation (PPT - 900KB)Panel Questions Presentation (PPT - 166KB)Whang Presentation (PPT - 186KB)
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November 18, 2009 Meeting Materials-- FDA Generated
Waiver (DOC - 79KB)Acknowledgement (PDF - 18KB)CAD Agenda (PDF - 49KB)CAD Draft 510K Guidance (PDF - 165KB)Draft Clinical Guidance Published (PDF - 141KB)Epidemiologic Review Mammography CADe (PDF - 147KB)Epidemiologic Review Lung and Colon CADe (PDF - 74KB)CADe FDA Discussion Questions (PDF - 29KB)CADe 24 Hour Summary (PDF - 69KB)Transcript: November 18, 2009 (PDF - 608KB)MITA Observations Presentation (PPT - 452KB)ACR and SBI Statement Presentation (PPT - 66KB)DeLucia Presentation (PPT - 2.2MB)Giger Presentation (PPT - 399KB)Nishikawa Presentation (PPT - 383KB)
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