Overview of South Korean Guidelines for Approval of Large Language or Multimodal Models as Medical Devices: Key Features and Areas for Improvement

Seong Ho Park; Geraldine Dean; Ernest Montañà Ortiz; Joon-Il Choi

doi:10.3348/kjr.2025.0257

Overview of South Korean Guidelines for Approval of Large Language or Multimodal Models as Medical Devices: Key Features and Areas for Improvement

Korean J Radiol. 2025 Jun;26(6):519-523. doi: 10.3348/kjr.2025.0257. Epub 2025 Apr 17.

Authors

Seong Ho Park¹, Geraldine Dean^{2

3

4}, Ernest Montañà Ortiz³, Joon-Il Choi⁵

Affiliations

¹ Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. parksh.radiology@gmail.com.
² Telemedicine Clinic Ltd. (a Unilabs company), Barcelona, Spain.
³ Unilabs AI Centre of Excellence, Barcelona, Spain.
⁴ NHS Southwest London, London, United Kingdom.
⁵ Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

No abstract available

Keywords: Approval; Artificial intelligence; Generative; Large language model; Large multimodal model; Medical device; Monitoring; Regulation; Software.

Publication types

Editorial