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510(k) Data Aggregation

    K Number
    K072960
    Device Name
    CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
    Manufacturer
    Date Cleared
    2007-11-08

    (20 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CDP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Users of CDP 5000 can perform the following tasks: - Query and retrieve images from the CDP 5000 Archive, using u any third party workstation capable of performing DICOM query/retrieve functions. - Use DIAGNET network viewer to search, retrieve and . manipulate patient images. - Create DICOM compliant portable media (i.e. CD-R) I containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application. Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting). Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.
    Device Description
    The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Users of CDP 5000 can perform the following tasks: - . Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions. - L Use DIAGNET network viewer to search, retrieve and manipulate patient images. - . Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application. Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking: measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting). Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist, and others. The CDP 5000 Ensemble is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The DIAGNET Viewer software, which is copied to every CD produced, runs automatically when the CD is placed in any Windows-based PC; it allows the examinee to view, manipulate, perform measurements on, and post-process the received images. The images can then be saved, copied, and/or sent to a file, emailed, or included in a report in process.
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