Professional Use & Disclaimer

The CRT IR LifeScanCare is an adjunctive thermal assessment device intended for use by qualified and appropriately trained healthcare practitioners.

The device is supported by FDA 510(k) clearance for the United States market. FDA 510(k) Number: K971956. Information generated by the CRT IR LifeScanCare, including thermal measurements, thermal patterns, physiological observations, and the AI-supported Findings Report, is intended to support professional assessment and decision-making.

The CRT IR LifeScanCare is not intended to replace professional medical advice, examination, diagnosis, treatment, or other appropriate healthcare services.

The AI-supported Findings Report is an aid to professional review and does not independently establish the presence or absence of breast cancer or any other medical condition.

The practitioner remains responsible for the professional interpretation and appropriate clinical use of the information provided by the CRT IR LifeScanCare, consistent with applicable laws, regulations, professional standards, and scope of practice.

For use by qualified healthcare practitioners.