Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K223659
    Device Name
    Jazz
    Manufacturer
    Date Cleared
    2023-09-22

    (290 days)

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

    AI Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.
    Device Description
    Jazz is a Software as a Medical Device (SaMD) consisting of a software intended to be a facilitating tool for the physicians, in the sense of a semi-automatic pipeline for the process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images. "Semi-automatic" refers to the possibility given to the physician to correct the segmentation of the software before saving.
    Ask a Question

    Ask a specific question about this device

    K Number
    K211715
    Device Name
    RetinAI Discovery
    Manufacturer
    Date Cleared
    2022-04-28

    (329 days)

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

    RetinAI Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
    Device Description
    The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1