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AI Tool Tracker

FDA-cleared CXR AI tools: what they detect, how they perform, and where trainees are most at risk.

The FDA AI landscape

FDA AI-Enabled Medical Device List

AI2Practice rebuilds this view from the FDA's downloadable AI-enabled medical-device list. Source data are credited to FDA; the visualization is adapted by AI2Practice for educational use and is not an FDA product or endorsement. The tracker below then narrows to chest radiography tools as a practical teaching example.

—of entries in the FDA AI-Enabled Medical Device List are led by the Radiology panel
—entries in the FDA AI-Enabled Medical Device List
—Radiology-panel entries
—entries in latest year

Entries by year and FDA lead panel

Source data: U.S. Food and Drug Administration, AI-Enabled Medical Devices List. Visualization adapted by AI2Practice for educational use. FDA describes the source as updated periodically and notes that the list is not comprehensive. Latest final-decision date in the local source: —. Last AI2Practice sync: —.

What does FDA status mean?

Not every entry on the FDA list should be described as “FDA-cleared.” Clearance, De Novo classification, and approval are distinct device pathways.

  • 510(k) clearanceFDA determines that a low- to moderate-risk device is substantially equivalent to an existing legally marketed predicate device.
  • De Novo classificationFDA classifies a novel low- to moderate-risk device type when there is no appropriate predicate.
  • Premarket Approval (PMA)FDA's most stringent device pathway, used primarily for high-risk Class III devices, based on evidence supporting safety and effectiveness.
About this data

Performance metrics from published validation studies. Real-world performance may differ. Educational reference, not product evaluation. Updated August 2026. See ACR AI Central for a comprehensive registry.

FDA-Cleared CXR AI Tools

Product Manufacturer Pathologies Mode Training Risk
Annalise CXR Annalise.ai 124 findings (broadest) Answer-delivery High
Lunit INSIGHT CXR Lunit Inc. 10+ abnormalities Answer-delivery + heatmap High
qXR Qure.ai 29+ abnormalities Answer-delivery + triage High
VUNO Med VUNO Inc. 6+ major findings Answer-delivery Medium
BriefCase CXR Aidoc PTX triage, critical findings Triage Medium
Red Dot Behold.ai Normal vs. abnormal Triage (binary) Low

Understanding Risk Levels

High = Finding-level diagnoses (answer-delivery). AI provides specific findings. Highest risk to independent skill development because the trainee's cognitive work is substantially replaced.

Medium = Triage or limited findings. AI handles detection/prioritization but the trainee still interprets. Moderate risk.

Low = Binary classification (normal vs. abnormal). The trainee must identify all specific findings. Lowest risk to independent skill development.

Performance by Pathology

Pathology Sensitivity Specificity Reliability Training Risk
PTX (moderate-large) 90–97% 92–98% Reliable High
PTX (small/subtle) 65–80% 85–95% Variable High
Consolidation 85–95% 80–92% Reliable High
Pleural effusion 88–96% 90–96% Reliable Medium
Lung nodules 70–90% 75–90% Variable High
Cardiomegaly 85–95% 80–92% Variable Medium
Rib fractures 60–85% 75–90% Variable Medium
Mediastinal 40–65% Variable Unreliable Low
Bone lesions 30–55% Variable Unreliable Low

Risk Mapping

Highest risk: pathologies where AI is good enough to replace search but not good enough to catch everything.

Highest Risk: AI is good but imperfect

Lung nodules, subtle pneumothorax, small consolidations. AI detects most (80–95%) so trainees stop searching independently, but it misses the subtle cases that require independent skill. The gap between AI's good-enough performance and 100% is where overreliance can undermine independent skill development; one form of this has been described as never-skilling.

Moderate Risk: AI creates miscalibration

Cardiomegaly, rib fractures, effusions. AI is generally good but has systematic biases (e.g., overcalling cardiomegaly on AP films, false-positive fractures at costochondral junctions). Primary risk: mis-skilling from absorbed errors.

Lower Risk: AI has limited coverage

Mediastinal abnormalities, bone lesions, soft tissue. Trainees must maintain independent assessment here. However, there is a risk of false completeness — believing a clean AI report means a normal study when AI simply does not evaluate these areas.

Key Questions About Your Department's AI

What pathologies does the AI detect?

Every AI tool has a defined detection list. Anything not on it is your responsibility alone. Know the boundaries of what your department's AI covers.

What is the false-negative rate for subtle findings?

Published sensitivity often reflects clear-cut cases. Subtle findings — small nodules, early architectural distortion, tiny pneumothoraces — may have significantly lower detection rates.

Triage mode or answer-delivery mode?

Triage preserves more of the trainee's diagnostic reasoning. Answer-delivery replaces more cognitive work. Know which mode your department's AI operates in — this shapes the training-risk profile.

Any known false-positive patterns?

Systematic false positives create mis-skilling risk. If the AI consistently overcalls certain findings, trainees may internalize those error patterns. Ask your attendings about known biases in your department's AI tools.