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510(k) Data Aggregation

    K Number
    K042647
    Device Name
    EXAM-PACS
    Manufacturer
    Date Cleared
    2004-10-07

    (9 days)

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

    COACTIV, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Exam-PACS™ is a device that receives digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
    Device Description
    Exam-PACS™ is comprised of various software modules that can be configured to provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
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