The American College of Radiology (ACR) Data Science Institute (DSI) has published a list of medical imaging artificial intelligence (AI) algorithms that have received clearance from the U.S. Food and Drug Administration (FDA).
Designed to simplify research by radiologists and developers, the list was obtained through a search of the FDA's website, according to the ACR DSI. Each listed algorithm has a summary that includes the manufacturer, FDA product code, body area, modality, and predicate device, as well as product testing and evaluation information related to product performance and clinical validation, the organization said.
Many of the models also match the ACR DSI's Define-AI use cases, the ACR DSI said. The list, which can be found on the ACR DSI's website, will be updated regularly.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
