Source record
Worklist triage for critical findings on chest radiographs
The source is the U.S. FDA list of AI/ML-enabled medical devices, used here with a source date of 1 May 2024. It is a public catalog of authorized devices, not a trial and not a comparison of chest-radiograph products. This entry uses the list only to point at a class of cleared worklist-triage tools, including products such as Lunit INSIGHT CXR, Annalise Enterprise CXR, and qXR. It reports no pooled sensitivity or specificity.
- Source date
- May 1, 2024 · Year 2024
- Evidence label
- Vendor-reported
- Source type
- News
Citation
U.S. FDA AI/ML-enabled device list
U.S. Food and Drug Administration. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. Public device list, dated in this index as 1 May 2024. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
Key public facts
- The page is FDA’s list of AI/ML-enabled devices, not a single-product study and not a head-to-head trial.
- This index date for the page is 1 May 2024. The list itself changes as new devices are authorized.
- The clinical job described is worklist triage for possible urgent chest-radiograph findings, such as pneumothorax, before the formal report.
- Names often cited for this job include Lunit INSIGHT CXR, Annalise Enterprise CXR, and qXR. Their labeled uses are not interchangeable.
- No pooled performance figure is stated. A flagged study still needs a radiologist’s report.
Directory entry for education and market scanning. Not medical advice and not an endorsement.