Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K083181
    Device Name
    QV-9000 UNIVERSAL SYSTEM
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Date Cleared
    2008-11-26

    (29 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM MEDICAL IMAGING, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QV-9000 Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
    Device Description
    The QV-9000 Universal System is a stationary, general purpose, X-ray imaging system used for acquiring radiographic exposures of various parts of the body including the skull, spinal column, chest, thorax, abdomen and extremities. The QV-9000 Universal System incorporates a floor-mounted vertical support column, with an attached rotating 'C' arm, an image receptor, an X-ray tube and collimator. The QV-9000 Universal System is compatible for use with either a digital or non-digital (film type) image receptor cabinet
    Ask a Question
    K Number
    K080905
    Device Name
    QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Date Cleared
    2008-07-16

    (106 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM MEDICAL IMAGING, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum / Canon CXDI Integration System provides diagnostic quality images to aid the physician with diagnosis. The System can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The System is not indicated for use in mammography.
    Device Description
    The Quantum / Canon CXDI Integration System consists of add-on software that will allow the use of the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Canon CXDI Series System, including models CXDI-40EG or CXDI-50G, as a fully integrated digital imaging system.
    Ask a Question
    K Number
    K072010
    Device Name
    QUANTUM DIREX SYSTEM
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Date Cleared
    2007-08-07

    (15 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM MEDICAL IMAGING, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.
    Device Description
    The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.
    Ask a Question
    K Number
    K023008
    Device Name
    UNIVERSAL SYSTEM, MODEL QV-800
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Date Cleared
    2002-11-13

    (65 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM MEDICAL IMAGING, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Medical Imaging, LLC Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
    Device Description
    The QV-800 Universal System is a walland floor-mounted column with an attached "swivel-arm". The QV-800 Universal System's "swivel-arm" design allows the x-ray tube and image receptor to remain in constant alignment as the arm is rotated and as the image receptor is anqulated. The QV-800 Universal System is designed for use in hospitals, imaging centers, and clinics.
    Ask a Question
    K Number
    K011486
    Device Name
    Q-RAD RADIOGRAPHIC SYSTEM
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Date Cleared
    2001-06-20

    (36 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM MEDICAL IMAGING, LLC.

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

    Page 1 of 1