🇺🇸 US Intended use and purpose

Intended use

The Legit.Health Plus is a software-aided adjunctive diagnostic device for use on clinical atypical cutaneous lesions suspicious for skin cancer or other skin injuries. Legit.Health Plus is a prescription device that uses a AI/ML algorithm, including computer-assisted/aided detection (CADe), that analyze images or other physical properties 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 trained in the clinical diagnosis and management of skin lesions. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.