Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990416
    Device Name
    OMNICORDER BIOSCAN SYSTEM
    Date Cleared
    1999-12-23

    (316 days)

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

    OMNICORDER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OmniCorder BioScan System is thermal camera based imaging device 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 who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer or other uses. This device is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    The OmniCorder BioScan System is an infrared camera device which provides the capability for imaging and recording of thermal data radiating from adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings; and in the home. It is a prescription device intended for use only by health care professionals.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1