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510(k) Data Aggregation

    K Number
    K100102
    Device Name
    CS-SERIES-FP
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2010-08-31

    (230 days)

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

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
    Device Description
    The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
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    K Number
    K093572
    Device Name
    R650 QDASM COLLIMATOR
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2010-02-03

    (77 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
    Device Description
    The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
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    K Number
    K070834
    Device Name
    CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2007-05-18

    (52 days)

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

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
    Device Description
    The Omega Medical Imaging, Inc. CS-Series systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration with options of either an elevating only or elevating/tilt patient table. The system may also be configure with a ceiling suspended "C" for bi-plane operation. The positioning of the source/receptor is achieved by motorized motions controlled by the operator. The imaging is achieved by way of an image intensifier/CCD camera with digital image processing.
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    K Number
    K062647
    Device Name
    E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2006-10-20

    (44 days)

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

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
    Device Description
    The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
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    K Number
    K050092
    Device Name
    R605 FACS COLLIMETER
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    2005-01-31

    (17 days)

    Product Code
    IZW
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
    Device Description
    The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
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    K Number
    K990055
    Device Name
    B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    1999-02-02

    (26 days)

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

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To support the Diagnostic Source Assembly & Image Receptor used in performing general-purpose diagnostic fluoroscopic procedures.
    Device Description
    The B-400 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of verforming general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from +145 degrees Left Anterior Oblique (LAO) to 55 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails.
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    K Number
    K970947
    Device Name
    B-350 CEILING MOUNTED C-POSITIONER
    Manufacturer
    OMEGA MEDICAL IMAGING, INC.
    Date Cleared
    1997-05-14

    (61 days)

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

    OMEGA MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To support the Diagnostic Source Assembly & the Image Receptor used in performing general purpose diagnostic fluoroscopic procedures.
    Device Description
    The B-350 Ceiling Mounted C-Positioner is a device intended to hold an X-Ray tube and an image intensifier 180° apart in a "C" configuration for the purpose of performing general purpose diagnostic fluoroscopic procedures. The C-Positioner allows variable positioning of the X-Ray tube/Image Intensifier from 30 degrees Left Anterior Oblique (LAO) to 120 degrees Left Posterior Oblique (LPO). The device will maintain isocenter throughout its full range of motorized movement. The entire assembly is mounted to a set of ceiling rails with a detent provided to lock the unit into place for use in creating a common isocenter between the Anterior/Posterior (A/P) and lateral planes. A microswitch controlled interlock system independently prevents X-Ray exposure anywhere outside the detent position.
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