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510(k) Data Aggregation

    K Number
    K242215
    Device Name
    Neurophet AQUA (V3.1)
    Manufacturer
    Date Cleared
    2024-10-25

    (88 days)

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

    Neurophet, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data.
    Device Description
    Neurophet AQUA is a fully automated MR imaging post-processing medical device software that provides automatic labeling, visualization, and volumetric quantification of brain structures from a set of MR images and returns segmented images and morphometric reports. The resulting output is provided in morphometric reports that can be displayed on Picture Archive and Communications Systems (PACS). The high throughput capability makes the software suitable for use in routine patient care as a support tool for clinicians in assessment of structural MRIs. Neurophet AQUA provides morphometric measurements based on T1 MRI series. The output of the software includes volumes that have been annotated with color overlays, with each color representing a particular segmented region, and morphometric reports that provide comparison of measured volumes to age and gender-matched reference percentile data. In addition, the adjunctive use of the T2 FLAIR MR series allows for improved identification of some brain abnormalities such as lesions, which are often associated with T2 FLAIR hyperintensities. Neurophet AQUA processing architecture includes a proprietary automated internal pipeline that performs segmentation, volume calculation and report generation. The results are displayed in a dedicated graphical user interface, allowing the user to: - Browse the segmentations and the measures, - Compare the results of segmented brain structures to a reference healthy population, - Read and print a PDF report Additionally, automated safety measures include automated quality control functions, such as scan protocol verification. which validate that the imaging protocols adhere to system requirements.
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    K Number
    K220437
    Device Name
    Neurophet AQUA
    Manufacturer
    Date Cleared
    2023-05-10

    (448 days)

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

    NEUROPHET, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Volumetric data may be compared to reference percentile data.
    Device Description
    Neurophet AQUA is a fully automated MR imaging post-processing medical device software that provides automatic labeling, visualization, and volumetric quantification of brain structures from a set of MR images and returns segmented images and morphometric reports. The resulting output is provided in morphometric reports that can be displayed on Picture Archive and Communications Systems (PACS). The high throughput capability makes the software suitable for use in both clinical trial research and routine patient care as a support tool for clinicians in assessment of structural MRIs. Neurophet AQUA provides morphometric measurements based on T1 MRI series. The output of the software includes volumes that have been annotated with color overlays, with each color representing a particular segmented region, and morphometric reports that provide comparison of measured volumes to age and gender-matched reference percentile data. Neurophet AQUA processing architecture includes a proprietary automated internal pipeline that performs segmentation, volume calculation and report generation. The results are displayed in a dedicated graphical user interface, allowing the user to: Browse the segmentations and the measures, Compare the results of segmented brain structures to a reference healthy population, Read and print a PDF report Additionally, automated safety measures include automated quality control functions, such as tissue contrast check, scan protocol verification, which validate that the imaging protocols adhere to system requirements.
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    K Number
    K221405
    Device Name
    Neurophet SCALE PET
    Manufacturer
    Date Cleared
    2022-08-05

    (81 days)

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

    NEUROPHET, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neurophet SCALE PET 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/FDG 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
    Neurophet SCALE PET is a standalone software product that automatically calculates standardized uptake value ratios (SUVR) and provides quantified calculation results for quantitative analysis of FDG and Amyloid PET images. The calculation results are intended to aid clinicians in diagnosing patients' pathologies. Furthermore, the function provided to visualize the results of the analysis of the image is designed to help clinicians perform accurate visual interpretation. Functions and workflow supported by the product are as follows: The user may set specified region as reference region, however, in order to achieve reliable constant count in the reference region, FDA recommends the selection of the pons or cerebellar white matter as reference region for assessment of SUVR in FDG PET imaging. Because this product complies with the standard DICOM medical imaging protocol, it can be used by being linked with picture archive and communications systems (PACS).
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