Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Premarket
Published
February 21, 2023
Last updated
February 21, 2023
Description
This document provides guidance for the industry and FDA staff on the conformance of medical X-ray imaging devices with IEC standards.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)