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Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration 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, Radiology。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov