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510(k) Data Aggregation

    K Number
    K093688
    Device Name
    CANON, MODEL URS-50RF
    Manufacturer
    VIRTUAL IMAGING, INC.
    Date Cleared
    2010-02-04

    (66 days)

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

    VIRTUAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The URS-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
    Device Description
    The Canon Dynamic/Static DR URS-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.
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    K Number
    K092439
    Device Name
    CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
    Manufacturer
    VIRTUAL IMAGING, INC.
    Date Cleared
    2009-11-30

    (112 days)

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

    VIRTUAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CXDI-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
    Device Description
    The Canon Dynamic/Static DR CXDI-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.
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    K Number
    K092280
    Device Name
    CYPHER DICOM PRINT SOLUTION
    Manufacturer
    VIRTUAL IMAGING, INC.
    Date Cleared
    2009-10-16

    (80 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRTUAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.
    Device Description
    CYPHER implements the necessary DICOM services to receive DICOM print jobs and provides an interface for printing the received data on a Windows™ printer. The device is designed for use with the CANON imagePRESS™ C1 Digital Print System. It consists of an Intel® 945GSE Mini-ITX Board in a shielded enclosure. The user interface is implemented on either an attached monitor or via the remote desktop function inherent in Windows XP. Power is supplied via an external UL listed 12 volt power supply.
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    K Number
    K083725
    Device Name
    RADPRO ION
    Manufacturer
    VIRTUAL IMAGING, INC.
    Date Cleared
    2009-01-22

    (38 days)

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

    VIRTUAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RadPro ION Mobile Fluoroscopy Systems are designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures The system may be used for other imaging applications at the physician's discretion
    Device Description
    The RadPro ION Mobile Fluoroscopy Systems (Multiple Models) are mobile x-ray units which employ unage intensifier units and have various options for image display and storage The units are used to equip a radiological room of general surgery, orthopedic, traumatology and cardiology The CCD camera is characterized by high contrast and sensitivity and no persistence of image The camera head include a mage rotation and image reversal system The automatic dose control, which acts either on KV and mA values, allows the user to reduce step by step the x-ray radiation to the minimum value, in accordance with the thickness and the density of the screened part All the configurations can accept connection to a digital memory, which allows to store and display in real time the ımage on the monitor only with a very little x-ray dose The new control panel with an alphanumerical display permits a fast and easy use by a rational and simple symbology, this console by an extension cable, could be located on the patient support to enable the c-arm control by the operator itself The system employs a Dose Area Product (DAP) meter for compliance with the US performance standard requirements
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    K Number
    K070390
    Device Name
    FLUOROPRO RF DIGITAL IMAGING SYSTEM
    Manufacturer
    VIRTUAL IMAGING, INC.
    Date Cleared
    2007-04-05

    (55 days)

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

    VIRTUAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.
    Device Description
    The FluoroPro RF Digital Imaging System is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The FluoroPro RF Digital Imaging System allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1024) may be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The FluoroPro RF Digital Imaging System enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.
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