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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MOS FDA class 2

    Coil, Magnetic Resonance, Specialty

    Radiology

    View full classification →

    The Specialty Magnetic Resonance Coil is a radiology device used as a component of MRI systems to improve signal reception from specific anatomical regions, enabling higher quality imaging of targeted areas such as the spine, extremities, or head. Classified as FDA Class 2 under 21 CFR 892.1000 in the Radiology specialty, it requires 510(k) premarket notification. The product code is MOS, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    0.55T 12Ch Breast Coil
    HD 8Ch Wrist Array
    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
    Smart Fit TorsoCardiac 1.5T
    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
    3.0T AIR 32CH HNA
    dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
    InkSpace Imaging Small Body Array (SBA12PH30x)
    e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
    16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
    InkSpace Imaging Small Body Array
    XENOVIEW 3.0T Chest Coil
    dS Wrist coil 8ch 1.5T
    dS Knee Coil 8ch 1.5T
    dS FootAnkle Coil 8ch 1.5T
    iLoop Interventional Coil 0.55T
    Contour Hand/Wrist (Q7000232)
    Contour Shoulder
    Smart Fit Knee 3.0T
    InkSpace Imaging Small Body Array
    16 Breast Coil
    dS Breast Coil 7ch 1.5T
    Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
    1.5T HD T/R Knee Array (10-F34127)
    IGAR System (1001.A)
    XENOVIEW 3.0T Chest Coil
    8ch T/R Knee Coil
    31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
    Contour Knee
    3.0T 16ch AIR AA
    XENOVIEW 3.0T Chest Coil
    8ch Wrist Coil
    InkSpace Imaging Body Array
    16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
    8ch Wrist Coil
    1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
    dS Sentinelle Breast 16ch 1.5T Coil
    dS Sentinelle Breast 16ch 3.0T Coil
    Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
    32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
    OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T
    dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
    InkSpace Imaging Pediatric Body Array
    dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
    ds Head 32ch 3.0T
    8ch Flex Suite
    1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
    Flex Body Speeder
    1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
    Flex Body SPEEDER

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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