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510(k) Data Aggregation

    K Number
    K071964
    Device Name
    MIM 4.1 (SEASTAR)
    Manufacturer
    MIMVISTA CORP.
    Date Cleared
    2007-09-26

    (72 days)

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

    MIMVISTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists and physicists. MIM 4.1 (SEASTAR) is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT. MRI. CR. DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following indications: - . Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. - . Create, display and print reports from medical images. - Registration, fusion display, and review of medical images for diagnosis, . treatment evaluation, and treatment planning. - . Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. - Localization and definition of objects such as tumors and normal tissues in . medical images. - . Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. - Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans
    Device Description
    MIM 4.1 (SEASTAR) is a software package designed for use in diagnostic imaging. It is a stand-alone software package which operates on Windows 2000/XP. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET, ECAT PET, SPECT, CT and MRI. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring, and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space. MIM 4.1 (SEASTAR) aids the efficiency of medical professionals in the creation of contours defining, but not limited to, normal and tumor tissues. The software automatically generates contours using a deformable registration technique which registers pre-contoured patients to target patients. Registrations are either between a serial pair of intra-patient volumes or between a pre-existing atlas of contoured patients and a patient volume. This process facilitates contour creation or re-contouring for adaptive therapy. MIM 4.1 (SEASTAR) additionally functions as a medical image and information management system intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The system has the ability to send data to DICOM-ready devices for image storage, retrieval and transmission.
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    K Number
    K062163
    Device Name
    MIMVIEWER
    Manufacturer
    MIMVISTA CORP.
    Date Cleared
    2006-09-22

    (56 days)

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

    MIMVISTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIMviewer software program is used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIMviewer provides tools for image review, manipulation, and analysis that assist physicians both inside and outside the medical environment.
    Device Description
    MIMviewer is a software package designed for use in diagnostic imaging which operates on Windows 2000/XP, MacOS X 10.4+ and Linux. MIMviewer is designed to be used as a standalone software package, as a remote viewing client for the MIM (K060816) software package, or as CD-ROM DICOM viewer for referring physicians. MIMviewer provides the physician with the means to display, register and fuse medical images from multiple modalities including PET, SPECT, CT and MRI.
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    K Number
    K060816
    Device Name
    MIM 4.0 (NEURO
    Manufacturer
    MIMVISTA CORP.
    Date Cleared
    2006-05-16

    (50 days)

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

    MIMVISTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.
    Device Description
    MIM 4.0 (NEURO) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM FET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve, Region of Interest (ROI) contouring and quantitative/statistical analysis of PET/SPECT brain scans through nonlinear registration to template space.
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    K Number
    K052379
    Device Name
    MIM 3.5 (CIRCA)
    Manufacturer
    MIMVISTA CORP.
    Date Cleared
    2005-10-31

    (62 days)

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

    MIMVISTA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIM 3.5 (CIRCA) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. Finally, the ROI feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to turnors and organs. The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as, SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including turnors, organs, and cardiac left ventricular cavity.
    Device Description
    MIM 3.5 (CIRCA) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM PET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve and ROI contouring.
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