Are there any medical image analysis tools that have FDA clearance for clinical decision support?

Yes. There are a number of FDA-cleared medical image analysis tools that are used for clinical decision support—though the exact scope varies by product, imaging modality, and intended use.

Common examples

These tools typically fall into areas like:

• Radiology triage / prioritization
• Computer-aided detection (CAD)
• Measurement / quantification
• Image reconstruction or enhancement
• Workflow support

Examples of FDA-cleared products and categories include:

• Aidoc – AI tools for detecting and flagging findings in CT, X-ray, and other modalities to help prioritize cases.
• Viz.ai – AI-assisted detection and triage for conditions like stroke, pulmonary embolism, and aneurysm.
• RapidAI – Imaging analytics for stroke and vascular conditions.
• HeartFlow – Noninvasive coronary CT analysis to support assessment of coronary artery disease.
• Butterfly Network / GE / Siemens / Canon / Philips – Some image acquisition, enhancement, and analysis features may be cleared depending on the exact product/version.
• ICAD / Hologic / ScreenPoint / context-specific CAD tools – Especially in mammography and breast imaging.

Important caveat

“FDA cleared” does not mean the software makes the final diagnosis. In most cases, it is cleared as:

• an adjunct to physician interpretation,
• a triage/prioritization aid, or
• a quantification/decision-support tool.

How to verify

The best way to confirm is to check:

1. The FDA 510(k) database or De Novo listings
2. The vendor’s intended use statement
3. The specific model/version and imaging indication

If you want, I can also give you:

• a list of specific FDA-cleared tools by imaging modality,
• a comparison table of indications and workflow use,
• or help you look up a particular vendor/product.