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
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 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230008 | DermaSensor | Dermasensor, Inc. | Jan 12, 2024 | DENG |
Top Applicants
- Dermasensor, Inc. — 1 clearance
