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US FDA Final Guidance – Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)]

Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)]

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