Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices, Radiation-Emitting Products
Topics
Premarket
Published
September 1, 2016
Last updated
May 13, 2019
Description
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and FDA Staff. Covers premarket requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)