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510(k) Data Aggregation

    K Number
    K033690
    Device Name
    TROPHYPAN AND TROPHYPAN C
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2004-02-20

    (88 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K033419
    Device Name
    STV PRO 2
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2004-02-02

    (98 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STV PRO 2 is: - a camera which delivers color images of the oral cavity, - a communication tool which allows the patient and dentist to view the patient's oral cavity
    Device Description
    Not Found
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    K Number
    K023346
    Device Name
    TROPHYPAN
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2003-01-03

    (88 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROPHYPAN Panoramic Dental X-Ray System is to be used as an external source of X-ray for imaging of the dento-maxillo-facial area and provides digital radiographic images only through the built-in DIGIPAN ( K012514), digital imaging system.
    Device Description
    TROPHYPAN Panoramic Dental X-Ray System
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    K Number
    K012514
    Device Name
    DIGIPAN / DPI
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2001-12-21

    (137 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trophy Radiologie digital imaging kit, DIGIPAN, can replace the conventional film for primary diagnostic purpose. The image generated is displayed on a computer monitor. The image can then be archived through computer storage and archival means. Referral copies of the image can be obtained with optional hard copy systems.
    Device Description
    DIGIPAN/DPI Digital Kit for Panoramic X-ray Device
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    K Number
    K991455
    Device Name
    ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    1999-06-25

    (60 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
    Device Description
    The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit. The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit.
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    K Number
    K991912
    Device Name
    MODIFICATION TO DIGIPAN
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    1999-06-22

    (15 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units : OP100, manufacturer Instrumentarium, K912893 ; OrthoSlice OS1000, manufacturer ASAHI, K991455 pending ; Panoura Ultra, manufacturer YOSHIDA, K number unknown to us ; X-Caliber, manufacturer ASAHI, K number unknown to us. The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referal copies of the image can be obtained with optional hard copy systems.
    Device Description
    Not Found
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    K Number
    K961826
    Device Name
    DIGIPAN
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    1996-09-23

    (133 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962337
    Device Name
    ELITYS OR ELITYS-E
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    1996-07-25

    (38 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TROPHY RADIOLOGIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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