Clinical-use disclaimer

Last updated 5 October 2026 · NAIQ

Assistive decision support only

Lung26 highlights candidate pulmonary nodules on low-dose CT, estimates their size, density and malignancy likelihood, and suggests an ACR Lung-RADS® v2022 category. These outputs are suggestions to support a qualified radiologist. They are not a diagnosis, and Lung26 must not be used as the sole basis for any clinical decision.

Regulatory status

Lung26 is not registered as a medical device with the Central Drugs Standard Control Organisation (CDSCO, India), the US FDA, or under the EU Medical Device Regulation. Hospitals using Lung26 in clinical care are responsible for local governance approval and for validating performance on their own scanners and patient population.

Known limitations

• Candidate detection is classical image analysis tuned for sensitivity; it produces false positives and can miss nodules, particularly juxta-pleural, juxta-vascular and very small or ground-glass lesions.
• The malignancy classifier was trained and tested on the public LIDC-IDRI dataset (held-out accuracy 0.86, macro AUC 0.95, three classes). Results on other populations may differ.
• Measurements are in-plane, single-slice estimates. Lung-RADS growth rules require a prior examination and are not applied automatically.
• Density type is inferred from mean attenuation and must be confirmed by the reader.

Responsibility

The signing radiologist is solely responsible for the interpretation and the final report. Every AI finding must be reviewed and accepted, edited or rejected before a report is signed.

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