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Hologic
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#	Item
111	Selenia Dimensions C-View User Instructions Introduction and General Information United States federal law restricts this device to use by, or on the order of, a physician. Add to Reading List Source URL: www.fda.gov Language: English Health informatics Hologic Medical physics Radiology Mammography Picture archiving and communication system DICOM Stereoscopy Breast cancer Medicine Medical imaging Telehealth
112	FDA Executive Summary Meeting of the Radiological Devices Advisory Panel On October 24, 2012, the panel will discuss, make recommendations, and vote on a premarket approval application supplement (P080003/S001) to expand Add to Reading List Source URL: www.fda.gov Language: English Mammography Breast cancer screening Breast cancer Breast implant Digital mammography Radiology Digital infrared thermal imaging in health care Medicine Cancer screening Hologic
113	Radiological Health Medical Devices Panel October 24, 2012 Hologic Selenia Dimensions 3D System with C-View Software Module Questions for Panel Discussion FDA would appreciate panel discussion the following aspects of th Add to Reading List Source URL: www.fda.gov Language: English Biopsy Mammography Excision Food and Drug Administration Medicine Hologic Cancer screening
114	Scientific Formal (Paper) Presentations CODE: MSVB31-08 SESSION: Breast Series: Emerging Technologies in Breast Imaging Recall Rate Reduction with Tomosynthesis during Baseline Examinations: Preliminary Assessment from a Add to Reading List Source URL: www.fda.gov Language: English Hologic Radiology Mammography Screening Breast cancer Digital mammography Medicine Cancer screening Ribbon symbolism
115	P080003/S001 Hologic Selenia Dimensions C-View Software Module FDA Panel Pack Post-Approval Study A post-approval study should not be required for the C-View software module for the Selenia Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research Food and Drug Administration Pharmaceutical industry Design of experiments Hologic Clinical trial Medical device Nintendo 3DS Medicine Health Pharmaceutical sciences
116	Scientific Formal (Paper) Presentations CODE: MSVB31-07 SESSION: Breast Series: Emerging Technologies in Breast Imaging Reading Time of FFDM and Tomosynthesis in a Population-based Screening Program DATE: Tuesday, Novemb Add to Reading List Source URL: www.fda.gov Language: English Mammography Projectional radiography Hologic Breast cancer screening Screening Breast cancer DBT Cancer Medicine Cancer screening Ribbon symbolism
117	P080003/S001 Hologic Selenia Dimensions C-View Software Module Sponsor Executive Summary Table of Contents P080003/S001 Hologic, Inc Panel Pack Add to Reading List Source URL: www.fda.gov
118	SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL INFORMATION Device Generic Name: Add to Reading List Source URL: www.fda.gov Language: English Hologic Ribbon symbolism Breast surgery Radiology Mammography X-ray computed tomography Breast cancer Breast implant Clinical trial Medicine Medical imaging Cancer screening
119	P080003/S001 Hologic Selenia Dimensions C-View Software Module Sponsor Executive Summary - Redacted FDA Panel Pack Table of Contents Add to Reading List Source URL: www.fda.gov Language: English X-ray computed tomography Mammography Picture archiving and communication system Breast cancer screening DICOM Radiology Magnetic resonance imaging Digital infrared thermal imaging in health care Single-photon emission computed tomography Medicine Medical imaging Hologic
120	P080003/S001 Hologic Selenia Dimensions C-View Software Module Draft CD Label C-View™ v2[removed]Software Installation DVD Add to Reading List Source URL: www.fda.gov