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510(k) Data Aggregation

    K Number
    K092328
    Device Name
    MED-SEG, MODEL BTMS 1000
    Date Cleared
    2010-07-26

    (356 days)

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

    BARTRON MEDICAL IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MED-SEG is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units), computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. In addition to general PACS use, this system can be used by trained professionals (e.g. physicians, radiologists, nurses, medical technicians, and assistants) to separate 2D images into "digitally related" sections or regions that, after colorization, can be individually labeled by the user. These images can be used to find appropriate window/level settings, to facilitate report generation and communication, or for other uses. These processed images should not be used for primary image diagnosis. Only DICOM "for presentation" uncompressed or non-lossy compressed images can be used on an FDA cleared or approved monitor for primary image diagnosis in mammography.
    Device Description
    MED-SEG™ software is a Picture Archiving and Communications System (PACS) for radiological image processing, storage, display and communication. The system can receive digital images via a secure internet communication link. The system incorporates parallel-computing algorithms that perform high-speed segmentation and regionalization. The system does not contact the patient nor does it control any life sustaining devices. A clinician interprets the images and information displayed by the system. providing ample opportunity for human intervention in the clinical decision process.
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