BEUDAMED
    Product Code: QDG FDA class 2 21 CFR 878.4550

    Parathyroid Autofluorescence Imaging Device

    General, Plastic Surgery

    The Parathyroid Autofluorescence Imaging Device is an adjunct surgical imaging tool that uses autofluorescence to visualize and detect parathyroid tissues or structures during general surgery; it is not intended to provide a diagnosis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QDG under regulation 878.4550 in the General and Plastic Surgery specialty. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    5
    Years Active
    7

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    Basic Information

    Product Code
    QDG
    Device Class
    FDA class 2
    Regulation Number
    878.4550
    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

    An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K253303 Dendrite Imaging System
    K250455 FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
    K233564 FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
    K230898 FLUOBEAM® LX Red
    K190891 Fluobeam LX
    DEN170092 Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

    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.