Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [De Novo Classifications](/submissions/SU/de-novo-classifications) → [21 CFR 878.1830](/submissions/SU/de-novo-classifications/878.1830) → QZS — Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

# QZS · Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

_General, Plastic Surgery · 21 CFR 878.1830 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/QZS

## Overview

- **Product Code:** QZS
- **Device Name:** Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
- **Regulation:** [21 CFR 878.1830](/submissions/SU/de-novo-classifications/878.1830)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230008](/device/DEN230008.md) | DermaSensor | Dermasensor, Inc. | Jan 12, 2024 | DENG |

## Top Applicants

- Dermasensor, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QZS](https://fda.innolitics.com/productcode/QZS)

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