Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges-Reference-Cited by-同舟云学术

Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges

Published:2023-06-23 Issue:05 Volume:10 Page:
ISSN:2329-4302
Container-title:Journal of Medical Imaging
language:
Short-container-title:J. Med. Imag.

Author:

Petrick Nicholas¹,Chen Weijie¹,Delfino Jana G.¹,Gallas Brandon D.¹,Kang Yanna²,Krainak Daniel²,Sahiner Berkman¹,Samala Ravi K.¹

Affiliation:

1. U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States

2. U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Silver Spring, Maryland, United States

Publisher

SPIE-Intl Soc Optical Eng

Subject

Radiology, Nuclear Medicine and imaging

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