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510(k) Data Aggregation

    K Number
    K020783
    Device Name
    TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
    Manufacturer
    TELESIS TECHNOLOGIES INC.
    Date Cleared
    2002-06-07

    (88 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELESIS TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for adjunctive diagnostic screening for detection of breast cancer or other uses.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Telesis Digital Infrared Thermal Image System, Spectrum 9000MB.

    The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on regulatory approval based on equivalence, not on the detailed results of performance studies against specific acceptance criteria.

    Therefore, I cannot provide the requested table and study details.

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