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510(k) Data Aggregation

    K Number
    K140380
    Device Name
    OPERA SWING
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Date Cleared
    2014-09-26

    (224 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL MEDICAL MERATE S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Opera Swing is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. The device is intended for use in: - Skeleton - Chest and lungs - Pediatrics - Emergency/traumatology - Gastroenterology - Urology and gynecology - Linear tomography - Digital angiography - Stitching
    Device Description
    Not Found
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    K Number
    K082243
    Device Name
    PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Date Cleared
    2008-11-07

    (92 days)

    Product Code
    OWB, IZI, JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL MEDICAL MERATE S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
    Device Description
    The PRECISION RXi System was originally cleared by the FDA under 510(k) K041605. This submission describes design changes including modifications to the positioner tilting/elevating movement and the compressor.
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    K Number
    K041605
    Device Name
    PRECISION RXI ANALOG X-RAY SYSTEM
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Date Cleared
    2004-06-30

    (15 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL MEDICAL MERATE S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are intended for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
    Device Description
    Not Found
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