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Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.
Petrick, Nicholas; Chen, Weijie; Delfino, Jana G; Gallas, Brandon D; Kang, Yanna; Krainak, Daniel; Sahiner, Berkman; Samala, Ravi K.
Affiliation
  • Petrick N; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
  • Chen W; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
  • Delfino JG; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
  • Gallas BD; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
  • Kang Y; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Silver Spring, Maryland, United States.
  • Krainak D; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Silver Spring, Maryland, United States.
  • Sahiner B; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
  • Samala RK; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
J Med Imaging (Bellingham) ; 10(5): 051804, 2023 Sep.
Article in En | MEDLINE | ID: mdl-37361549
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Guideline / Prognostic_studies Language: En Journal: J Med Imaging (Bellingham) Year: 2023 Type: Article Affiliation country: United States
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Guideline / Prognostic_studies Language: En Journal: J Med Imaging (Bellingham) Year: 2023 Type: Article Affiliation country: United States