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510(k) Data Aggregation

    K Number
    K171977
    Device Name
    miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
    Date Cleared
    2018-08-02

    (398 days)

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

    Hinacom Software and Technology, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use. miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use. miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.
    Device Description
    miPlatform v3.0 and miPlatform ZFP Viewer is the extension application software of miPlatform medical imaging information system. User can achieve mobile office through the software which is installed in PC, smart mobile phone and other mobile terminals. - . Understanding and analyzing patient's information and medical image in real time. - . Processing, diagnosing and sharing images in real time. Note that when used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use. - . Support three-dimensional image viewing and processing. - Support image analysis and real-time data synchronization exchange in real-time conference.
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    K Number
    K131424
    Device Name
    MIPLATFORM MEDICAL IMAGING SUITE
    Date Cleared
    2013-07-12

    (56 days)

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

    HINACOM SOFTWARE AND TECHNOLOGY, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    miPlatform is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data. The software performs digital image processing, analysis, reviewing, communication and storage. miPlatform supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standard. miPlatform also supports multidimensional image visualization, measurement and analysis tools, and reporting algorithms. The user interface is designed to follow typical clinical workflow patterns to process, review, validate/edit and analyze digital images. The software supports the following image analysis options: Vessel Analysis is an option intended for viewing or displaying vascular obstructive disease by providing a non-invasive survey of a patient's coronary or peripheral arteries. Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Physicians can manually measure the lumen width to obtain percentage stenosis calculations. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics. Coronary Calcium Scoring is an option intended for cardiac scoring from CT image derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Physicians can use semi-automatic tools in Coronary Calcium Scoring to mark calcified lesions of coronary arteries, and automated computation of Agatston scoring will be performed and presented in a report. miPlatform supports a real-time image-based conference option with integrated audio/video capability. Multiple users may log into the system and participate in the conference from different locations via internet connection. 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 cleared monitor that meets technical specifications reviewed and accepted by FDA.
    Device Description
    miPlatform is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data. The software performs digital image processing, analysis, reviewing, communication and storage. miPlatform supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standard. miPlatform also supports multidimensional image visualization, measurement and analysis tools, and reporting algorithms. The user interface is designed to follow typical clinical workflow patterns to process, review, validate/edit and analyze digital images. The software supports the following image analysis options: Vessel Analysis and Coronary Calcium Scoring. miPlatform supports a real-time image-based conference option with integrated audio/video capability.
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