BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    3.0T AIR 32CH HNA

    K Number: K253738 · Decision Jan 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    12
    Review Days
    60

    Basic Information

    Device Name
    3.0T AIR 32CH HNA
    K Number
    K253738
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare Coils (Usa Instruments, Inc.)
    Date Received
    November 24, 2025
    Decision Date
    January 23, 2026
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

    Similar 510(k) Clearances

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

    0.55T 12Ch Breast Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    HD 8Ch Wrist Array

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    Smart Fit TorsoCardiac 1.5T

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

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

    Other Clearances by Ge Healthcare Coils (Usa Instruments, Inc.)

    K Number Device Name
    K223378 3.0T 16ch AIR AA
    K182504 3.0T Air MP M, 3.0T Air MP L
    K180666 48CH Head Coil
    K172695 AIR Anterior Array, AIR Posterior Array
    K163205 48CH Head Coil
    K143389 3.0T GEM RT Open Array
    K123327 1.5T GEM RT OPEN ARRAY
    K122174 PEDIATRIC POSITIONER PAD SET
    K103365 DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
    K101492 8 CHANNEL CARDIAC PHASED ARRAY COIL
    Search all 12 clearances from Ge Healthcare Coils (Usa Instruments, Inc.) →