Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products.

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Bibliographic Details
Title: Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products.
Authors: Kikuchi T; Department of Radiology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke-shi, Tochigi, 329-0498, Japan.; Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan., Walston SL; Department of Artificial Intelligence, Graduate School of Medicine, Osaka Metropolitan University, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan., Takita H; Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan., Mitsuyama Y; Department of Diagnostic and Interventional Radiology, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.; Smart Data and Knowledge Services Department, German Research Center for Artificial Intelligence (DFKI GmbH), 67663, Kaiserslautern, Germany., Ito R; Department of Innovative BioMedical Visualization, Nagoya University Graduate School of Medicine, Showa-ku, Nagoya, Japan., Hashimoto M; Department of Radiology, Keio University School of Medicine, Shinjukuku, Tokyo, Japan., Nakaura T; Department of Diagnostic Radiology, Kumamoto University Graduate School of Medicine, Chuo-ku, Kumamoto, Japan., Hyakutake H; Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan., Kawabe S; Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan., Mori H; Department of Radiology, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke-shi, Tochigi, 329-0498, Japan., Ueda D; Medical AI Promotion Institute Co., Ltd., Life Science Building, 12-9 Nihonbashi Odemmachi, Chuo-ku, Tokyo, Japan. daiju.ueda@mapi-jp.org.; Department of Artificial Intelligence, Graduate School of Medicine, Osaka Metropolitan University, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. daiju.ueda@mapi-jp.org.; Center for Health Science Innovation, Osaka Metropolitan University, Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. daiju.ueda@mapi-jp.org.
Source: Japanese journal of radiology [Jpn J Radiol] 2026 Jun; Vol. 44 (6), pp. 1095-1111. Date of Electronic Publication: 2026 Jan 14.
Publication Type: Journal Article; Scoping Review
Journal Info: Publisher: Springer Country of Publication: Japan NLM ID: 101490689 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1867-108X (Electronic) Linking ISSN: 18671071 NLM ISO Abbreviation: Jpn J Radiol Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1867-108X
DOI:10.1007/s11604-025-01942-y