FDA Product Code QZS: Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
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.
Leading manufacturers include Dermasensor, Inc..
FDA 510(k) Cleared Software-aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer Devices (Product Code QZS)
About Product Code QZS - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QZS since 2024, with 0 receiving FDA clearance (average review time: 344 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QZS devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →