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510(k) Data Aggregation

    K Number
    K132183
    Device Name
    DICOM VIDEO
    Manufacturer
    BAR CODE COMPUTER LTD
    Date Cleared
    2013-10-03

    (80 days)

    Product Code
    LMA, COM
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the network. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.
    Device Description
    The DICOM Video is a software package, which is installed in an Off - The - Shelf Host PC. The device is interfaced and configured to a hospital Local Area Network (LAN). The DICOM Video receives patients' list from the Hospital Modality Work List (MWL ) server and digital files input data (in text, images or video formats). The device records the received data, stores it, transfers the studies into standard DICOM files, and transmits the DICOM files via the LAN to the Hospital PACS. The DICOM Video can be interfaced to a Host Acquisition Device in order to receive analog video signals. The data is digitized, stored, optionally edited, transferred into standard DICOM files, and transmitted as DICOM files via the LAN to the Hospital PACS. The device can also retrieve DICOM studies from the PACS and display them on the user screen.
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    K Number
    K130636
    Device Name
    TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
    Manufacturer
    VIDAR SYSTEMS CORP.
    Date Cleared
    2013-06-07

    (88 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation. These devices are not intended to be used for primary diagnosis in mammography applications.
    Device Description
    The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation. The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white or blue LED illuminator, a lens, mirrors, and a CCD linear array detector. This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.
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    K Number
    K130406
    Device Name
    DIAGNOSTICPRO EDGE
    Manufacturer
    VIDAR SYSTEMS CORP.
    Date Cleared
    2013-04-29

    (69 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, .including .printed and .radiographic .film. The .target users of these devices are .medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation. The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.
    Device Description
    The device consists of a film digitizer with multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation. The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector. This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.
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    K Number
    K102476
    Device Name
    TELERADPRO
    Manufacturer
    VIDAR SYSTEMS CORP.
    Date Cleared
    2010-10-07

    (38 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleradPRO film digitizer is intended for making digital copies of medical xray films.
    Device Description
    The device consists of a film digitizer with single-film or multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The Digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.
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    K Number
    K093809
    Device Name
    VIDAR DENTAL FILM DIGITIZER
    Manufacturer
    VIDAR SYSTEMS CORP.
    Date Cleared
    2010-01-07

    (29 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading applications.
    Device Description
    The Dental Film Digitizer is a medical device used to convert x-ray films into a digital format. The device uses high end imaging components and design characteristics specifically geared towards the complexity of x-ray film data; offering the user a low noise, high resolution reproduction of the medical film.
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    K Number
    K091288
    Device Name
    MEDI-6000 MEDICAL IMAGE DIGITIZER
    Manufacturer
    MICROTEK INTERNATIONAL, INC.
    Date Cleared
    2009-08-14

    (105 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.
    Device Description
    The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.
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    K Number
    K063424
    Device Name
    FILM DIGITZER, MODEL 2908 MAMMO PRO
    Manufacturer
    ARRAY CORP.
    Date Cleared
    2006-12-21

    (38 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images. The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis. The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.
    Device Description
    Film Digitizer, Model 2908 Mammo Pro
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    K Number
    K042484
    Device Name
    NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
    Manufacturer
    NAI TECHNOLOGY PRODUCTS
    Date Cleared
    2004-10-20

    (37 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAI Tech Products Medical Digital Recorder is intended for use in Radiology applications to capture and digitize images and record them to single or multiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).
    Device Description
    Medical Digital Video Recorder
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    K Number
    K033637
    Device Name
    MEDICAL IMAGE DIGITIZER, MODEL 2908
    Manufacturer
    ARRAY CORP.
    Date Cleared
    2003-12-17

    (28 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.
    Device Description
    Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.
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    K Number
    K032022
    Device Name
    DIGITAL IMAGER
    Manufacturer
    PYRAMID MEDICAL, INC.
    Date Cleared
    2003-09-02

    (64 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Product Code :

    LMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.
    Device Description
    Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection.
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