The statements made regarding the SmartPath Imager have not been evaluated by the Food and Drug Administration (FDA). The SmartPath System is currently intended for research use only. This medical device has not yet been evaluated, cleared, or approved by the FDA. Its safety and effectiveness have not been established nor confirmed by FDA-approved research. SmartPath is not currently available for sale in the United States as a diagnostic aid or medical device for human pathology. This material is provided solely for informational purposes and does not substitute professional medical advice. It also does not constitute an offer to promote the device for any medical use.