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510(k) Data Aggregation

    K Number
    K253499

    Validate with FDA (Live)

    Device Name
    Ascent3T Neonatal Magnetic Resonance Imaging System
    Manufacturer
    Eyas Medical Imaging, Inc.
    Date Cleared
    2026-01-26

    (89 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 1
    Reference & Predicate Devices
    K193215,K170978
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a whole-body magnetic resonance scanner designed for neonates and infants. The system can produce cross-sectional images of the internal structure of the head, body or extremities in any orientation.

    Images produced by the Ascent3T show the spatial distribution of protons exhibiting magnetic resonance. Images produced by the Ascent3T, when interpreted by a trained physician, may provide information useful in diagnosis.

    The Ascent3T Neonatal Magnetic Resonance Imaging System is suitable for neonates and infants weighing up to 9kg (19.8 lbs).

    Device Description

    The Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a high-field magnetic resonance imaging system, appropriately sized and optimized for the neonate and infant population, with a format that allows siting near point of care. The Ascent3T presents a solution for the technical limitations associated with using an adult-size MRI system and provides clinicians with an improved ability to visualize and diagnose disease in the neonatal patient population.

    The Ascent3T is equipped with a small format superconducting magnet designed for neonate applications. The system is designed to operate at 3.0 Tesla and achieves a high level of homogeneity over a 24cm diameter spherical volume using passive shims. The magnet requires a minimal amount of helium and no quench pipe. These features, in combination with the size and weight of the magnet, support near-patient siting.

    The Ascent3T patient table is detachable and can serve as a patient transport device. The patient table includes a tabletop cradle with features for securing the patient during scanning. The patient table is mobile, providing flexibility in workflow based on institutional needs and preferences.

    The Ascent3T contains a menu of pulse sequences intended to provide the user with a variety of sequences useful for producing images for diagnostic purposes.

    Key Features of the Ascent3T:

    • 3T superconducting magnet with 25cm patient bore.
    • Minimal helium capacity with no quench pipe required.
    • Gradient system: 80 mT/m maximum amplitude per axis, 300 mT/m/ms slew rate per axis.
    • Real-time SAR monitoring and alerts with Normal and First-Level Controlled Operating Modes.
    • Capable of producing images in axial, sagittal, coronal, and oblique orientations.
    • Accommodates neonates and infants weighing up to 9 kg (19.8 lbs).
    • Detachable, mobile patient table with built-in safety features.
    AI/ML Overview

    N/A

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