FDA-Cleared AI Directory
Radiology AI Cleared by the FDA
Most cleared healthcare AI reads pictures. This is where the scans live, and it is by far the busiest field on the list.
Radiology got here first for a boring reason: the input is already a digital file. A chest CT is a stack of images sitting on a server, which is exactly what a trained model wants to see, and the result can be checked against what the radiologist said.
That head start shows. Radiology holds more cleared AI products than every other field on this list put together.
The important split inside radiology is not which body part a product looks at. It is what the product is permitted to say. Some are allowed to move an urgent scan to the front of the queue and nothing more. Some are allowed to mark a spot on the image. A small number are allowed to help call it. Those are different device types with different rules, and mixing them up is how a purchase goes wrong.
Device Types in Radiology
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| AI Triage and Notification Software for Radiology | Moves a scan that may show something urgent to the front of the reading queue. It is not allowed to say what it found. | 87 | July 13, 2026 |
| AI Lesion Prioritization Software for Radiology | Sorts studies by how likely they are to contain a lesion, so the most suspicious ones get read first. | 41 | July 8, 2026 |
| AI Cancer Detection Software for Radiology | Marks places on a scan that may be cancer, and in some cases gives a score for how suspicious they look. | 39 | August 14, 2026 |
| AI Diagnostic Software for Suspicious Lesions | Helps characterize a lesion that has already been found, rather than finding it in the first place. | 23 | July 2, 2026 |
| Lung CT Computer-Aided Detection | Finds and measures nodules on a chest CT, and tracks whether they changed since last time. | 20 | May 27, 2026 |
| AI Fracture Detection Software | Marks possible broken bones on an X-ray, aimed at the ones that get missed on a busy night. | 11 | August 28, 2026 |
| AI-Guided Image Acquisition | Helps take a better picture in the first place, by guiding the person holding the probe or tuning the scan. | 9 | July 15, 2026 |
| CT Colonography Computer-Aided Detection | Flags possible polyps on a CT scan of the colon, as a second read. | 4 | December 3, 2014 |
| Chest X-Ray Computer-Aided Detection | Marks possible findings on a plain chest X-ray. | 1 | October 8, 2004 |
| Quantitative Imaging AI With a Change Control Plan | Measures something on a scan, and comes with an agreed plan letting the maker update the model without starting over. | 1 | February 24, 2023 |
Newest Radiology Clearances
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Rayvolve AZchest | AZmed | August 28, 2026 | K261378 |
| Transpara (2.1.0) | Screenpoint Medical B.V. | August 14, 2026 | K260898 |
| CadAI-B Dx | BeamWorks, Inc. | August 12, 2026 | K260086 |
| See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | July 28, 2026 | K260303 |
| ThinkSono Guidance | ThinkSono GmbH | July 15, 2026 | K260338 |
| Rapid Vessel Occlusion (Rapid VO) | iSchemaview | July 13, 2026 | K261085 |
| CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | July 8, 2026 | K253751 |
| Koios DS (3.8) | Koios Medical, Inc. | July 2, 2026 | K253884 |
| MammoScreen® (5) | Therapixel | June 26, 2026 | K260714 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | June 18, 2026 | K260729 |
| Saige-Dx | DeepHealth, Inc. | June 15, 2026 | K253825 |
| Sonio Suspect | Sonio | June 4, 2026 | K261519 |
| HeartFocus | Deski | June 3, 2026 | K260780 |
| Synapse Lung Nodule AI | Fujifilm Corporation | May 27, 2026 | K254075 |
| BriefCase-Triage | Aidoc Medical , Ltd. | May 14, 2026 | K261317 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.