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  6. Division of Imaging, Diagnostics, and Software Reliability
  1. CDRH Offices

Division of Imaging, Diagnostics, and Software Reliability

Who We Are

The Division of Imaging, Diagnostics, and Software Reliability (DIDSR) within CDRH’s Office of Science and Engineering Laboratories (OSEL) develops methods for evaluating the image quality of emerging imaging systems; develops methods for characterizing new medical image display devices; evaluates the dose reduction potential of new image reconstruction methods, and assesses the performance of Artificial Intelligence and Machine Learning algorithms. DIDSR also develops state-of-the-art methods for the design of clinical trials involving imaging devices and the evaluation of resulting trial data to enable more efficient and effective utilization of imaging data and more powerful clinical studies.

  • Medical Imaging and Diagnostics
  • Artificial Intelligence and Machine Learning
  • Augmented and Virtual Reality
  • Digital Pathology
  • Credibility assessment in modeling
  • Post-market signal response

The technical disciplines of the Division’s staff include physics, electrical and biomedical engineering, mathematics and statistics, computer science, and medical radiology.

Contact Us

For specific phone numbers and email, see the CDRH Management Directory by Organization.

For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.

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