Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff

Issue Date: February 21, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Radiological Health, Radiology
Status: Final

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff

This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Download the Guidance Document