BEUDAMED
    Product Code: LHM FDA class 1 21 CFR 884.2982

    System, Thermographic, Liquid Crystal

    Obstetrics/Gynecology

    A liquid crystal thermographic system is a diagnostic imaging device that uses cholesteric liquid crystals to produce thermographic images of body surface temperature variations, historically used as an adjunctive tool for assessing breast tissue and vascular abnormalities. The device is FDA Class 1, the lowest risk category, subject only to general controls and requiring 510(k) notification in this instance. It bears product code LHM and is regulated under 21 CFR 884.2982 within the Obstetrics/Gynecology specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    LHM
    Device Class
    FDA class 1
    Regulation Number
    884.2982
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    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
    K872962 BREAST-SCAN(TM)