HHS FDA Creates Class II Category for Machine Learning Radiology Software
June 17, 2026
June 17, 2026
WASHINGTON, June 17 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as a Class II medical device category.
The software-only devices use machine learning algorithms to analyze radiological images and produce quantitative imaging outputs. According to FDA, the systems can perform functions including image view selection, seg . . .
The software-only devices use machine learning algorithms to analyze radiological images and produce quantitative imaging outputs. According to FDA, the systems can perform functions including image view selection, seg . . .