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510(k) Data Aggregation

    K Number
    K141743
    Device Name
    FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
    Date Cleared
    2014-10-03

    (95 days)

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

    RADIOLOGY SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
    Device Description
    This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is required. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators.
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    K Number
    K132294
    Device Name
    GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
    Date Cleared
    2013-11-12

    (112 days)

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

    RADIOLOGY SOLUTIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
    Device Description
    This is a complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
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