BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    RCT800

    K Number: K260462 · Decision Apr 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    24
    Review Days
    56

    Basic Information

    Device Name
    RCT800
    K Number
    K260462
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ray Co., Ltd.
    Date Received
    February 12, 2026
    Decision Date
    April 9, 2026
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Ray Co., Ltd.

    K Number Device Name
    K251798 RCT700
    K251109 SMARTDent
    K243903 RCT600
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    K232325 RAYSCAN a-Expert
    K232287 RAYSCAN a-Expert3D
    K230753 RCT800
    K213226 RCT700
    K211105 Ear-Friendly Mask
    K192737 RCT800
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