BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Demetra BDEM-01 Dermatoscope

    K Number: K192829 · Decision Dec 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    60
    Review Days
    72

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Demetra BDEM-01 Dermatoscope
    K Number
    K192829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barco N.V.
    Date Received
    October 2, 2019
    Decision Date
    December 13, 2019
    Product Code
    PSN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PSN Light Based Imaging

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PSN), ordered by most recent decision date.

    DeepX DermoSight Dermatoscope

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Demetra Dermatoscope BDEM-01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Demetra Analytics Toolkit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VivaScope System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VIVASCOPE SYSTEM, MODEL 1500, 3000

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SIASCOPE V

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Barco N.V.

    K Number Device Name
    K243307 LCD Monitor (MDEC-2523)
    K242008 Coronis OneLook
    K233693 Nio Color 8MP (MDNC-8132)
    K230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
    K213957 Demetra Dermatoscope BDEM-01
    K203364 MDPC-8127
    K201408 Demetra Analytics Toolkit
    K203106 Nio Fusion 12MP (MDNC-12130)
    K191845 Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
    K173381 Nexxis OR
    Search all 60 clearances from Barco N.V. →