BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ICI P AND S SERIES IR CAMERAS

    K Number: K073581 · Decision Jul 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    204

    Basic Information

    Device Name
    ICI P AND S SERIES IR CAMERAS
    K Number
    K073581
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.2980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TEXAS INFRARED
    Date Received
    December 20, 2007
    Decision Date
    July 11, 2008
    Product Code
    LHQ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LHQ System, Telethermographic (Adjunctive Use)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LHQ), ordered by most recent decision date.

    ThermPix Thermovisual Camera

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ThermPix Thermovisual Camera

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Smile-100 System

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    IRIS-XP

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Thermidas IR System (ThIR-A615)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    InTouch Thermal Camera

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology
    View all