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510(k) Data Aggregation

    K Number
    K231133
    Device Name
    neo315
    Date Cleared
    2024-07-22

    (458 days)

    Product Code
    Regulation Number
    892.1000
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    Applicant Name (Manufacturer) :

    Neoscan Solution GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The neo315 is a magnetic resonance diagnostic device which is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.
    Device Description
    The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.
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