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510(k) Data Aggregation

    K Number
    K032350
    Device Name
    INFRARED SCIENCES BREASTSCAN IR SYSTEM
    Manufacturer
    INFRARED SCIENCES CORP.
    Date Cleared
    2004-02-20

    (205 days)

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

    INFRARED SCIENCES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Sciences BreastScan IR™ System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    The BreastScan IR ™ System is a new, non-invasive procedure offered to women, of any age, to determine current breast health by measuring various temperature parameters in the breast. Designed exclusively by Infrared Sciences Corp., BreastScan IR ™ System has demonstrated its effectiveness as an adjunctive tool for the doctor to use along with mammography, ultrasound, or clinical examination. The entire procedure takes approximately 10 minutes with the results immediately available, to assist in the doctor's determination of breast health. The results are analyzed by proprietary algorithms and then presented in a non-subjective report. The procedure does not involve any compression of the breast, or touching of the breast in any way. The patient simply sits in a chair, facing an infrared camera for a few minutes. Components of the system include: Infrared System Device Color Inkjet Printer TVNCR Medical Cart BreastScan IR Server Air Cooling Device Patient Chair
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