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510(k) Data Aggregation

    K Number
    K032471
    Device Name
    TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
    Manufacturer
    TITRONICS RESEARCH & DEVELOPMENT CO.
    Date Cleared
    2003-10-10

    (60 days)

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

    **TITRONICS RESEARCH **& DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TyTron C-500IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic, and inflammatory conditions. Use of the TyTron C-500IR System is not intended to be the sole diagnostic procedure for these diseases and conditions.
    Device Description
    The TyTron C-500IR is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging system composed of an infrared camera which is interfaced to a computer with the intent of viewing and digitally storing thermal patterns generated by the surface of the human body.
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    K Number
    K974208
    Device Name
    TYTRON C-3000
    Manufacturer
    TITRONICS RESEARCH & DEVELOPMENT CO.
    Date Cleared
    1998-02-03

    (85 days)

    Product Code
    HCS
    Regulation Number
    882.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **TITRONICS RESEARCH **& DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TyTron C-3000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by professional health care providers. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care.
    Device Description
    The TyTron C-3000 is a hand held paraspinal thermographic scanning system. It consists of two probes which each contain infrared sensors designed to be placed on either side of the spinal column to detect temperatures. With the aid of a computer assisted program the system is capable of recording and graphing thermal differentials (right to left thermal asymmetries) on a horizontal scale. It also records direct temperatures on the vertical scale.
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