Date Published:
Tue, 09/09/2008This guidance document provides recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. See Sections 1.6.14, 1.7.5 and the checklist in Section 6 for recommendations specific to hardware, software, and associated changes. This guidance documents refers the reader to FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices for additional details.