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510(k) Data Aggregation

    K Number
    K023925
    Device Name
    MARK I THERMAL IMAGER
    Manufacturer
    IX-DR, INC.
    Date Cleared
    2003-02-11

    (78 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    IX-DR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thermal Imaging is a medical imaging modality for use as an adjunctive procedure to support other diagnostic modalities. For example, thermal imaging of breasts can demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure.
    Device Description
    Not Found
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