- No clinical evidence has been established supporting the following claims in patients with active lung or pleural disease that could obscure pulmonary nodules, including fibrosis, emphysema, compressed lung, scarring, severe lung disease, and in patients with objects in or around the lungs that could obscure pulmonary nodules. The effectiveness of the device may vary depending on nodule prevalence and type.
- Defined as a recommendations for further advanced imaging, based upon the Fleischner Society guidelines for pulmonary nodule management. MacMahon, Heber, et al. "Guidelines for Management of Small Pulmonary Nodules Detected on CT Scans: A Statement from the Fleischner Society." Radiology 237.2(2005):395-400.