From X-Rays to AI: Navigating US Regulations in Radiological Health
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Figure 7-4. Application of Cybersecurity Principles and How They Impact the Risk Management
Process.............................................................................................................................. 109
Figure 7-5. Health Software Life Cycle Processes.............................................................................. 110
Figure 8-1. Schematic Representation of (a) The Number of FDA Approvals and Clearances Per
Year and (b) The Number of Device Authorizations by FDA Regulation Panel as of
31 December 2022. ..........................................................................................................114
Figure 8-2. A Brief Chronology of Computer-Assisted Device Evolution. .......................................118
Figure 8-3. Schematic Representation of Number of Computer-Assisted Detection Clearances
by (a) FDA Category and (b) by Year Cleared According to Data From the American
College of Radiology’s Data Science Institute – AI Central............................................ 119
Figure 8-4. Overview of Computer-Assisted Diagnosis Applications................................................ 121
Figure 8-5. Schematic Representation of Various Development Stages in SaMD. ............................125
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Figure 7-4. Application of Cybersecurity Principles and How They Impact the Risk Management
Process.............................................................................................................................. 109
Figure 7-5. Health Software Life Cycle Processes.............................................................................. 110
Figure 8-1. Schematic Representation of (a) The Number of FDA Approvals and Clearances Per
Year and (b) The Number of Device Authorizations by FDA Regulation Panel as of
31 December 2022. ..........................................................................................................114
Figure 8-2. A Brief Chronology of Computer-Assisted Device Evolution. .......................................118
Figure 8-3. Schematic Representation of Number of Computer-Assisted Detection Clearances
by (a) FDA Category and (b) by Year Cleared According to Data From the American
College of Radiology’s Data Science Institute – AI Central............................................ 119
Figure 8-4. Overview of Computer-Assisted Diagnosis Applications................................................ 121
Figure 8-5. Schematic Representation of Various Development Stages in SaMD. ............................125