BEUDAMED
    Product Code: QZS FDA class 2 21 CFR 878.1830

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

    General, Plastic Surgery

    The software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer (product code QZS) is a Class 2 General, Plastic Surgery prescription device (regulation 878.1830) that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a lesion classification. Requiring 510(k) clearance, it is intended for use by physicians not trained in clinical diagnosis and management of skin cancer as a second-read adjunctive device following identification of a suspicious lesion, and is not intended as a standalone diagnostic or to confirm a clinical diagnosis. It is not an implant and is not life-sustaining.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    QZS
    Device Class
    FDA class 2
    Regulation Number
    878.1830
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN230008 DermaSensor

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.