BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    i_ Field 1.5T Superconducting Magnetic Resonance Imaging System

    K Number: K221025 · Decision Jul 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    2
    Review Days
    86

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
    K Number
    K221025
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mri Division,Beijing Wandong Medical Technology Co., Ltd.
    Date Received
    April 6, 2022
    Decision Date
    July 1, 2022
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.

    uMR Astra

    FDA 510(k)
    FDA Class 2 ·Radiology

    APERTO Lucent MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    S-scan Open (100001800)

    FDA 510(k)
    FDA Class 2 ·Radiology

    nordicAudio (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Embrace Neonatal MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Mri Division,Beijing Wandong Medical Technology Co., Ltd.

    K Number Device Name
    K192650 i_Space 1.5T Superconducting Magnetic Resonance Imaging System