FDA Guidance Documents·· 原文未提供具体时分
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff
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FDA 官方历史目录记录；Final guidance；发布日期：2022-09-28。官方主题：Premarket, 510(k), Digital Health, Radiology, Labeling。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov