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510(k) Data Aggregation

    K Number
    K233247
    Device Name
    Heuron ICH
    Manufacturer
    Date Cleared
    2024-05-15

    (230 days)

    Product Code
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heuron Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K231642
    Device Name
    Veuron-Brain-pAb3
    Manufacturer
    Date Cleared
    2023-10-13

    (130 days)

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

    Heuron Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Veuron-Brain-pAb3 is software for the registration, fusion, display, and analysis of medical images from multiple modalities including MRI and PET. The software aids clinicians in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables anatomic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratio (SUVR) within target reqions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.
    Device Description
    The Veuron-Brain-pAb3 is a standalone software for quantitative analysis of the PET amyloid by automatically calculating the "Standardized Uptake Value Ratio (SUVR)". The calculated result is only used as a reference to support the accuracy of the medical professional's diagnosis of dementia in patients. It also helps with accurate visual interpretation through visualization functions. Various PET amyloid images can be processed by using diverse options provided for users to choose in the image process.
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    K Number
    K203279
    Device Name
    Veuron-Brain-mN1
    Manufacturer
    Date Cleared
    2022-07-12

    (613 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heuron Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence. When used in combination with other clinical information, the Veuron-Brain-mN1 application may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures with magnetic susceptibility contrasts in brain 3T MR images.
    Device Description
    Veuron-Brain mN1 is a post-processing software intended to provide visualization, manipulation and reconstruction capabilities, including susceptibility map-weighted images, of 3D gradient multi echo brain 3T MR images. The Veuron-Brain-mN1 aids in the clinical analysis of brain structures from MR images.
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    K Number
    K213801
    Device Name
    Veuron-Brain-pAb2
    Manufacturer
    Date Cleared
    2022-02-04

    (60 days)

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

    Heuron Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Veuron-Brain-pAb2 is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radiotracer and disease combinations.
    Device Description
    The Veuron-Brain-pAb2 is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result is just used as a reference supporting the accuracy of the diagnosis of patients' dementia for the medical professional. It also helps with accurate visual interpretation through visualization functions. Various amyloid PET images can be processed by providing a variety of options for users to choose in the image process.
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    K Number
    K203142
    Device Name
    Veuron-Brain-pAb
    Manufacturer
    Date Cleared
    2021-01-15

    (87 days)

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

    Heuron Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Veuron-Brain-pAb is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.
    Device Description
    The Veuron-Brain-pAb is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result supports the accuracy of the diagnosis of patients' dementia for the medical professional. It also helps with accurate visual interpretation through visualization functions. Various amyloid PET images can be processed by providing a variety of options for users to choose in the image process.
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