🇺🇸 US Intended use and purpose

Intended use

The device is a software-aided adjunctive diagnostic device for use on clinical atypical cutaneous lesions suspicious for skin cancer or other skin injuries.

The device is a prescription device that uses AI/ML technology, including computer-assisted/aided detection (CADe), that analyze images of a skin lession, and returns a classification of the skin lesion and quantifiable data on the intensity, count and extent of clinical signs to assist in the decision regarding referral of the patient to a dermatologist.

The device is intended for use by a physician not necessarily trained in the clinical diagnosis and management of skin lesions. It is not for use as a standalone diagnostic. Is not for use to confirm a clinical diagnosis.