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
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Premarket
Published
September 28, 2022
Last updated
September 27, 2022
Description
A guidance document for industry and FDA staff on premarket notification submissions for computer-assisted detection devices in radiology.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)