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510(k) Data Aggregation

    K Number
    K191504
    Device Name
    PowerDR
    Date Cleared
    2019-08-16

    (71 days)

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

    Radiology Information Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PowerDR™ Digital X-ray Imaging System is indicated for use as an X-ray imaging modality to acquire, process, display, quality assure and store digital medical X-ray images. The PowerDR™ Digital X-ray Imaging System is indicated for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not indicated for use in mammography.
    Device Description
    The PowerDR™ Console Application is a digital medical X-ray imaging system consisting of an X-Ray detector, computer hardware and the PowerDR™ software. The User supplies the X-Ray generator. The PowerDR™ Console Application is intended to enable a procedure of medical image acquisition, processing, display, quality assurance, and storage. The software interfaces to an X-Ray detector from variety of vendors to acquire raw pixel data. Its image-processing algorithms transform raw pixel data into diagnostic quality images and image sequences to aid the medical professional in diagnosis. For temporary storage, image data can be stored on the local computer. For long term storage, image data can be stored on a portable media device or a remote PACS (Picture Archive and Communication System) server. The PowerDR™ Digital X-ray Imaging System is intended for use in general radiographic and fluoroscopic examinations of any anatomy for adult, pediatric, and neonatal patients. It is not intended for use in mammography. The system can be sold with or without a computer, and with or without a compatible, previously cleared, digital receptor panel.
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    K Number
    K102849
    Device Name
    ACCULMAING
    Date Cleared
    2010-11-23

    (55 days)

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

    RADIOLOGY INFORMATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.
    Device Description
    Acculmaging is a Dynamic Link Library (DLL) module that takes a raw X-rav image generated by a CR or DR as its input and produces a fidelity-quality image for diagnostic purposes. It interfaces with radiological software to analyze digital image data and optimize the processing parameters applied to enhance detail and thus images' diagnostic quality. Acculmaging is not a standalone module and does not implement any user interfaces; it provides a dedicated image processing function to a top-level application running in the Microsoft Windows operating system. It is bound into a parent application that provides user interfaces and dynamically loads the DLL module, forming an integrated process; and, it can also be linked to a service module to provide the image processing service to other top-level applications.
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    K Number
    K970641
    Device Name
    RIS SCANVIEW SYSTEM (RSVS)
    Date Cleared
    1997-05-02

    (71 days)

    Product Code
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOLOGY INFORMATION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RSVS is intended for use as an image display and keyboard cutry node on a DICOM 3.0 network. It's principal anticipated functions are to merge bitmap images from image sources with keyboard input patient information to form DICOM 3.0 patient image files and provide quality assurance review of such files.
    Device Description
    The RIS Scan View System (RSVS) is a DICOM 3.0 compliant secondary capture image application. It can receive, store, transmit, and display images. It provides storage and query/remeval service using C-STORE Service. The RSVS issues a DICOM 3.0 association request, RSVS starts sending the image data to the storage service provider. In addition, it can merge information from its keyboard with bitmap images from imaging devices to create DICOM 3.0 image files. The RSVS is a Microsoft Window based application.
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