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510(k) Data Aggregation

    K Number
    K124048
    Device Name
    IMAGEQUBE
    Manufacturer
    INTUITIVE IMAGING INFORMATICS, LLC
    Date Cleared
    2013-01-29

    (29 days)

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

    INTUITIVE IMAGING INFORMATICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImageQube is intended for use by a physician or other medical professionals in the display and interpretation of medical images and demographic detail from all institutional imaging modalities, including, but not limited to, CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlays and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The ImageQube is designed for display, interpretation, storage and distribution of all modalities. Only pre-processed DICOM For Presentation images can be interpreted for primary diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be viewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor meeting all the technical specifications required by the FDA for the Performance of Screening and Diagnostic Mammography. Images that are printed to film must be done using an FDA-approved printer for the diagnosis of digital mammography images. Efficient mammography screening makes toolbars and thumbnails available on each monitor, while also handling DICOM overlay display. Acquired medical images may be displayed and manipulated further utilizing Multi-Planar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3-D display, sent to and retrieved by radiologists in-house at facilities or at remote sites, stored, archived or printed. The ImageQube can operate as an independent device, or can also be interfaced with Rational Imaging PACS systems. Annotated print pages, transcribed reports and Key Image Summaries can also be accessed.
    Device Description
    ImageQube is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including, but not limited to CT, MRI, NM, DR, US, PET Fusion, Angio and MG (including display of DICOM overlay and 3D Mammography images), along with secondary capture devices, such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multiplanar Reconstruction (MPR), Anatomic Triangulation (AT), Dynamic Cross-Referencing, Maximum Intensity Projection (MIP), Slab and 3D display are also available for optional use.
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    K Number
    K051037
    Device Name
    IMAGEQUBE PACS
    Manufacturer
    INTUITIVE IMAGING INFORMATICS, LLC
    Date Cleared
    2005-06-28

    (64 days)

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

    INTUITIVE IMAGING INFORMATICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImageQube is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The ImageQube Web system is designed for acquisition, storage, and distribution of all modalities. Device is also designed for primary interpretation of all modalities except manmography. Device is not to be used for primary imaging diagnosis in mammography and will be conspicuously labeled as such during display of mammography images. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Rational Imaging PACS Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.
    Device Description
    ImageQube is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources.. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.
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    K Number
    K031473
    Device Name
    RATIONAL IMAGING PACS
    Manufacturer
    INTUITIVE IMAGING INFORMATICS, LLC
    Date Cleared
    2003-10-30

    (174 days)

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

    INTUITIVE IMAGING INFORMATICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rational Imaging PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.
    Device Description
    Rational Imaging PACS is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.
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