Advisory Committees
-
2012 Meeting Materials of the Radiological Devices Panel
-
October 24, 2012: Meeting Materials FDA Generated
-
-
October 24, 2012: Meeting Materials Non-FDA Generated
Table of Contents (PDF - 120KB)Sponsor Executive Summary (PDF - 2.2MB)Glossary of Terms (PDF - 346KB)SSED (PDF - 460KB)Draft C-View CD Label (PDF - 118KB)Post Approval Study (PDF - 208KB)Draft C-View User Instructions (PDF - 653KB)Protocol 09 03 Rev 04 (Image Acquisition Protocol) (PDF - 541KB)Protocol 11 02 Rev 02 (Reader Study Protocol) (PDF - 100KB)Referenced Literature: Dorfman et al 1992 (PDF - 12KB)Referenced Literature: Gur et al 2010 (PDF - 14KB)Referenced Literature: Gur et al 2011 (PDF - 342KB)Referenced Literature: Hendrick 2010 (PDF - 400KB)Referenced Literature: Hendrick et al 1997 (PDF - 10KB)Referenced Literature: Hills et al 2008 (PDF - 22KB)Referenced Literature: NRC (PDF - 9KB)- Referenced Literature: Obuchowski 2010 (PDF - 14.7MB)
Referenced Literature: Obuchowski 2006 (PDF - 11KB)Referenced Literature: Pisano et al 2005 (PDF - 14KB)Referenced Literature: Rafferty et al 2007 (PDF - 8KB)Referenced Literature: Rosenberg et al 2006 (PDF - 14KB)Referenced Literature: Skaane et al 2001 (PDF - 342KB)Referenced Literature: Smith et al 2004 (PDF - 39KB)Referenced Literature: Tabar et al 2001 (PDF - 36KB)Sponsor Presentation: Oct. 24, 2012 (PDF - 9.9MB)
-
-
April 11, 2012: Meeting Materials FDA Generated - U-Systems
-
-
April 11, 2012: Meeting Materials Non-FDA Generated - U-Systems
P110006 U-Systems Final (PDF - 1MB)P110006 Final Executive Summary (PDF - 2.1MB)Sponsor Appendix USI2011001 (PDF - 288KB)Sponsor P110006 Final Proposed Package Insert (PDF - 76KB)Sponsor P110006 Final Proposed Physician Labeling (PDF - 110KB)Sponsor P110006 Final Proposed Summary of Safety and Effectiveness (PDF - 429KB)- Sponsor P110006 Final Proposed Training (PDF - 103KB)
Sponsor P110006 Final Table of Contents (PDF - 84KB)Sponsor P110006 Final Proposed Post Approval Study (PDF - 105KB)Sponsor Presentation: April 11, 2012 (PDF - 11.2MB)
-
-
April 12, 2012: Meeting Materials FDA Generated - Blood Irradiators
Panel Roster: Blood Irradiators (PDF - 23KB)FDA Executive Summary (PDF - 240KB)Executive Summary: Ref 1 (PDF - 1.5MB)Executive Summary: Ref 2 (PDF - 13KB)Executive Summary: Ref 3 (PDF - 24KB)Executive Summary: Ref 4 (PDF - 10KB)Executive Summary: Ref 5 (PDF - 12KB)Executive Summary: Ref 6 (PDF - 9KB)- Executive Summary: Ref 7 (PDF - 14KB)
Literature Review: Agarwal (PDF - 7KB)Literature Review: Anderson (PDF - 9KB)Literature Review: Anderson 2 (PDF - 9KB)Literature Review: Arseniev (PDF - 8KB)Literature Review: Butson (PDF - 9KB)Literature Review: Christensen 1 (PDF - 8KB)Literature Review: Christensen 2 (PDF - 9KB)Literature Review: Fagiolo (PDF - 8KB)Literature Review: Fearon (PDF - 9KB)Literature Review: Hirayama (DOC - 24KB)Literature Review: Janatpour (PDF - 8KB)Literature Review: Lavee et al (PDF - 9KB)Literature Review: Lowenthal (PDF - 9KB)Literature Review: Moroff (PDF - 10KB)Literature Review: Rosen (PDF - 9KB)Literature Review: Webb (PDF - 7KB)Presentation: O'Hara (PDF - 610KB)Presentation Session II: Shulman (PDF - 141KB)24 Hour Summary: Blood Irradiators (PDF - 74KB)Transcript: April 12, 2012 (PDF - 690KB)
-
-
April 12, 2012: Meeting Materials FDA Generated - Breast Transilluminators
- Agenda: April 12, 2012 (PDF - 19KB)
- Panel Roster: Breast Transilluminators (PDF - 16KB)
- FDA Executive Summary (PDF - 213KB)
Executive Summary Review: Ref 1 (PDF - 74KB)Executive Summary Review: Ref 2 (PDF - 5MB)Executive Summary Review: Ref 5 (PDF - 25KB)Executive Summary Review: Ref 6 (PDF - 12KB)Executive Summary Review: Ref 7 (PDF - 13KB)Executive Summary Review: Ref 9 (PDF - 11KB)Executive Summary Review: Ref 8 (PDF - 241KB)Executive Summary Review: Ref 10 (PDF - 42KB)Executive Summary Review: Ref 11 (PDF - 7KB)Executive Summary Review: Ref 12 (PDF - 8KB)Literary Review: Athanasiou (PDF - 8KB)Literary Review: Cheng (PDF - 10KB)Literary Review: Grosenick (PDF - 14KB)Literary Review: Leff (PDF - 15KB)Literary Review: Poellinger (PDF - 1KB)Literary Review: Poplack (PDF - 10KB)Literary Review: Rinneberg (PDF - 10KB)Literary Review: Schneider (PDF - 9KB)Literary Review: van de Ven 1 (PDF - 12KB)Literary Review: van de Ven 2 (PDF - 12KB)Presentation: Wersto (PDF - 434KB)- Presentation Session I: Shulman (PDF - 141KB)
24 Hour Summary: Breast Transilluminators (PDF - 78KB)
-
-
April 12, 2012: Meeting Materials Non-FDA Generated - Breast Transilluminators
-
-
-
