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510(k) Data Aggregation

    K Number
    K062742
    Device Name
    CR 85-X
    Manufacturer
    AGFA CORPORATION
    Date Cleared
    2006-10-13

    (29 days)

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

    AGFA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide diagnostic quality images to aid in physician diagnosis. Intended to provide diagnostic quality images to aid in physician diagnosis for general radiography and gastro-intestinal imaging applications.
    Device Description
    The predicate and newly modified devices are computed radiograpy imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system. The CR85-X and the ADC Compact Plus are similar. The CR85-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
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    K Number
    K062223
    Device Name
    AGFA MODEL CR30-X
    Manufacturer
    AGFA CORPORATION
    Date Cleared
    2006-09-01

    (30 days)

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

    AGFA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X is intended to be used mainly in chest, skeletal and gastro-intestinal x-ray imaging applications.
    Device Description
    The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system. The CR30-X and the CR25.0 are similar. The CR30-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
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    K Number
    K053634
    Device Name
    COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
    Manufacturer
    AGFA CORPORATION
    Date Cleared
    2006-01-17

    (19 days)

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

    AGFA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Agfa's Computed Radiography Systems with NX1.0 workstations are intended for use in the identification, generation, acquisition, processing and filing of computed radiography images in order to make them ready for interpretation by the physician. Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
    Device Description
    The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems system utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system. The NX1.0 and QS 3.0 (predicate) workstations are similar. The NX1.0 workstation includes a number of improvements including: - . A more intuitive user interface. - Enhanced image processing. . - Easier installation and updates, . - Enhanced image manipulation, display and export capabilities, . The basic principles of operation are unchanged.
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    K Number
    K052251
    Device Name
    DRYSTAR MODEL 5500
    Manufacturer
    AGFA CORPORATION
    Date Cleared
    2005-08-31

    (13 days)

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

    AGFA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drystar 5500M is a free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
    Device Description
    The device is the new Drystar 5500 and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The device has two input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images. Otherwise, the device is very similar to the cleared original Drystar 5500.
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