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Clinical Performance Assessment for CADe Devices in Radiology (FDA, Sep 2022)
FDA
Clinical Performance Assessment for CADe Devices in Radiology (FDA, Sep 2022)
FDA guidance on designing clinical performance studies for radiology CADe devices.
September 1, 2022
Published
FDA
Source
AI/ML SaMD
ai-ml-samd
FDA
fda
Topic
Open PDF
https://cdn.prod.website-files.com/5f10960649ee0832d2b92042/68ed51facf1195bc3438ed4d_FDA%20Guidance%20-CADe-Clinical-Perf-Guidance.pdf
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