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510(k) Data Aggregation

    K Number
    K073169
    Device Name
    SCIMAGE PICOMENTERPRISE
    Manufacturer
    SCIMAGE, INC.
    Date Cleared
    2008-01-09

    (61 days)

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

    SCIMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images. Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices. The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification. To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
    Device Description
    The PicomEnterprise software is a multi-modality comprehensive two-, three- and four-dimensional image presentation software system intended for acceptance, transfer, display, storage and digital processing of medical images. The PicomEnterprise software combines reconstruction and display algorithms for medical image analysis in the familiar Microsoft Windows environment. PicomEnterprise offers full compliance with DICOM 3.0 standard that permit transfer of data from medical devices to storage server and then to other DICOM compliant devices.
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    K Number
    K003484
    Device Name
    NETRA WORKSTATION AND NETRAMD SOFTWARE
    Manufacturer
    SCIMAGE, INC.
    Date Cleared
    2001-01-19

    (71 days)

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

    SCIMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960911
    Device Name
    NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
    Manufacturer
    SCIMAGE, INC.
    Date Cleared
    1996-05-29

    (84 days)

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

    SCIMAGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Netra™ Workstation System and NetraMD™ Software is intended for viewing and manipulation of high quality MRI, CT, Ultrasound and X-ray electronic images as an aid in diagnosis for the trained medical practitioner.
    Device Description
    The Netra™ Workstation System and NetraMD™ Software is a Medical Image Processing System and digital image communications system for use by the trained medical practitioner. The Netral Image Processing System receives electronic information from medical imaging devices and manipulates that data for purposes of visualization, communication, archiving, characterization, comparison to other images and image enhancement. It is similar in design to other such digital image communications system devices. It has microprocessor PC computer controlled solid state digital data and video receiving and transmission electronics and accessories.
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