Last updated: May 24, 2026
Evaluate AI for medical imaging by modality, intended use, FDA record, validation evidence, radiology workflow, and monitoring requirements.
Radiology, cardiology, dental, telehealth, and federal health teams evaluating imaging AI.
Connects imaging use cases with FDA-status verification and real deployment workflow checks.
| Medical risk | High |
|---|---|
| Best first step | Write the workflow in one sentence, decide who reviews the AI output, and test with a small controlled pilot before expanding. |
| Recommended posture | Use AI as supervised workflow support. Verify sources, privacy, human review, and regulatory fit before relying on outputs. |
These profiles are not rankings. They are starting points for checking vendor claims, privacy terms, FDA or regulatory posture, evidence, and workflow fit.
Aidoc describes radiology AI that helps prioritize findings, streamline workflows, activate care teams, and run through an aiOS platform; its FAQ and security pages point buyers to product-specific 510(k) notices, quality-system compliance, and cloud security review.
ScreenPoint describes Transpara as a breast AI suite for detection, density, and temporal-comparison workflows and states that Transpara is CE marked and FDA cleared for 2D and 3D mammography; FDA records list Transpara 2.1.0 under K241831 and Transpara Density under K232096.
Koios describes Koios DS Breast as FDA-cleared and CE-marked smart ultrasound software for breast cancer risk assessment; FDA K212616 materials describe Koios DS as an AI/ML CADx adjunct for diagnostic ultrasound examinations of suspicious breast lesions and thyroid nodules.
Compare medical imaging and radiology products · Open the category shortlist · Review source policy
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