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
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Digital Health, Labeling, Premarket
Published
September 28, 2022
Last updated
September 27, 2022
Description
This document provides guidance for industry and FDA staff on clinical performance assessment of computer-assisted detection devices in radiology.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)