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510(k) Data Aggregation

    K Number
    K211966
    Device Name
    Segment 3DPrint
    Manufacturer
    Medviso AB
    Date Cleared
    2022-05-06

    (316 days)

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

    Medviso AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediativ and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabrical replical replical replical replical replical replical replical replical by use of additive manufacturing methods. Segment 3DPrint is intended to be used by trained professionals in conjunction with expert clinical judgement.
    Device Description
    Seqment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods.
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    K Number
    K163076
    Device Name
    Segment CMR
    Manufacturer
    MEDVISO AB
    Date Cleared
    2017-04-05

    (153 days)

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

    MEDVISO AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Segment CMR is a software that display and analyzes medical images in DICOM-format using multi-slice, multi-frame and velocity encoded MR images. Segment CMR provides features for analysis of cardiac function, such as cardiac pumping and blood flow. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. Images and associated data analysis can be stored, communicated, rendered, and displayed within the system and across PACS system. The data produced by Segment CMR is intended to support qualified cardiologist, radiologist or other licensed professional healthcare for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
    Device Description
    Segment CMR is a software that displays and analyzes multi-slice, multiphase and velocity encoded DICOM compatible medical MR images. Segment CMR provides quantitative measures for analysis of function of the cardiovascular system. The data produced by Segment CMR is intended to be used to support qualified cardiologist, radiologist or other professional healthcare practitioners for clinical decision making. Functional, flow, valve, vessel, and tissue analysis is performed using standardized algorithms and user input. The quantification methods are validated and reproducible. The ventricular analysis is provided for usage in both pediatric (from newborn) and adult population. MR images may be imported from various sources including images stored on portable media, network storage devices, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors.
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    K Number
    K090833
    Device Name
    SEGMENT
    Manufacturer
    MEDVISO
    Date Cleared
    2009-05-12

    (47 days)

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

    MEDVISO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Segment is a software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Segment specifically analyzes the function of the heart and its major vessels using multi-slice, multi-frame and velocity encoded MR images. It provides clinically relevant and reproducible data for supporting the evaluation of the function of the chambers of the heart such as left and right ventricular volumes, ejection fractions, stroke volumes, peak ejection and filling rates, myocardial mass, regional wall thickness, fractional thickening and wall motion. It also provides quantitative data on blood flow and velocity in the arterial vessels and at the heart valves. Segment is tested on MR images acquired from both 1.5 T and 3 T MR scanners. The data produced by Segment is intended to be used to support qualified cardiologist, radiologist or other licensed professional healthcare practitioners for clinical decision making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
    Device Description
    Segment is a software for analysis of cardiovascular MR images. Segment provides clinical quantitative data by analyzing multi-slice, multi-phase DICOM compatible cardiovascular MR images. Functional and blood flow analysis is performed using 2D, 3D and 4D data sets using standard algorithms and user input. MR images may be imported from various sources including images stored on portable media, network storage devices, PACS, and other vendor systems and supports cardiovascular MR images from all of the major MRI scanner vendors. Segment can be used for quantitative and qualitative analysis of cardiovascular MR images.
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