General_plastic_surgery
DermaSensor
DermaSensor Inc.
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.
FDA Submission Metadata
- Submission number
- DEN230008
- Decision date
- January 2024
- FDA panel
- General and Plastic Surgery
- Product code
- QZS
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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