FDA 510(k) Radiology Devices

FDA 510(k) Radiology Devices - Regulatory Overview

FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.

Key modalities covered:

• X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
• Computed tomography (CT) - whole-body and dedicated CT scanners
• Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
• Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
• Radiation therapy - linear accelerators, brachytherapy and treatment planning
• Nuclear medicine - PET, SPECT and gamma camera systems