1 device · 1 company · 2024
Product code QZS: Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
1 device under product code QZS, 2024, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer. 21 CFR 878.1830, Class II. A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. MAUDE held 11 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| DermaSensorDEN230008 · De Novo | DermaSensor Inc. | General and Plastic Surgery | database entry |
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