美国FDA 指导原则 用于放射成像和放射设备数据的计算机辅助检测设备.[510(K)]上市前通知[510(K)]工业和食品药品监督管理局工作人员提交指南 英文原版.pdfVIP

Contains Nonbinding Recommendations 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 Document issued on September 28, 2022. Document originally issued on July 3, 2012. For questions about this document, contact RadHealth@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to . Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2009-D-0503. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an email request to CDRH- Guidance@ to receive a copy of the guidance. Please include the document number 1697 and complete title of the guidance in the request. Contains Nonbinding Recommendations Table of Contents I. Introduction 1 II. Background 2 III. Scope 2 IV. Describing the Device in a 510(k) 5 A. General Information 5 B. Algorithm Design and Function 6 C. Processing 7 D. Features 7 E. Models and Classifiers 7 F. Algorithm Training 8