Professional Use & Disclaimer

The CRT LifeScan 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 LifeScan, including thermal measurements, thermal patterns, physiological observations, and the AI-supported Findings Report, is intended to support professional assessment and decision-making.

The CRT LifeScan 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 LifeScan, consistent with applicable laws, regulations, professional standards, and scope of practice.

For use by qualified healthcare practitioners.

CRT: A Precision Thermal Assessment Tool with AI-Supported Findings for Adjunctive Breast Cancer Screening

CRT is a precision thermal assessment tool intended for adjunctive use in breast cancer screening. It provides stable, repeatable measurements of autonomic-related thermal patterns that may reflect underlying physiological changes. Using AI-supported pattern analysis, CRT helps clinicians highlight subtle thermal asymmetries and physiology-linked variations that may warrant closer attention.

As an adjunctive thermal assessment device, CRT offers clinicians objective temperature data that complements physical examination, patient history, and established breast-screening modalities. CRT does not replace mammography, ultrasound, MRI, or any primary diagnostic imaging method, nor is it intended to diagnose breast cancer. Instead, CRT supports clinical reasoning by providing AI-supported thermal pattern insights that may help inform decisions about further evaluation within a clinician’s existing diagnostic workflow.

CRT FDA 510(k) Number: K971956
Manufacturer: Life Scan Care Inc.