Overview

FDA regulates safety and effectiveness of radiology devices including radiography CT MRI ultrasound and nuclear medicine systems through device classification and premarket review.

Modality Focus

Device specific guidance covers diagnostic x ray CT mammography MRI ultrasound and nuclear medicine imaging systems and contrast agents.

Key Programs

Includes device premarket pathways 510k and PMA guidance recognized consensus standards and postmarket surveillance.

Clinical Impact

Manufacturers and facilities rely on FDA guidance for device labeling performance claims and safety reporting.