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510(k) Data Aggregation

    K Number
    DEN230043
    Device Name
    Notal Vision Home Optical Coherence Tomography (OCT) System
    Manufacturer
    Date Cleared
    2024-05-15

    (343 days)

    Product Code
    Regulation Number
    886.1600
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    Product Code :

    SAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hyporeflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.
    Device Description
    The NVHO System is a device that consists of two elements: - . Notal Home OCT device: patients use this to self-image their eyes using Spectral-Domain OCT: At the end of each scanning session the data is transmitted via a secured wireless communication to the Notal Health Cloud. - Notal Health Cloud: cluster of servers and analysis units on which the Notal OCT . Analyzer (NOA) analyzes the scans received from the Notal Home OCT device. Processed data are presented on a dedicated interactive web-application, the Notal Home OCT Web Viewer.
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