BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RAYSCAN

    DI: 08800003027019 · Model: Scan Ceph (SC) · Ray Co., Ltd
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RAYSCAN
    Primary DI
    08800003027019
    Version / Model
    Scan Ceph (SC)
    Company Name
    Ray Co., Ltd
    Labeler DUNS
    690324087
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-25
    Public Version
    2
    Public Version Date
    2026-04-15
    Public Version Status
    Update
    Public Device Record Key
    809c56cd-4494-45ef-b4d4-4d6d00f0220f

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OAS X-Ray, Tomography, Computed, Dental
    MUH System, X-Ray, Extraoral Source, Digital

    GMDN Terms

    Code Name
    44245 Stationary panoramic/tomographic dental x-ray system, digital

    Identifiers

    Type ID
    Primary 08800003027019

    Premarket Submissions

    Submission Number Supplement Number
    K142058 000
    K182614 000
    K182805 000
    K190812 000
    K192737 000
    K213226 000
    K230753 000
    K232287 000
    K232325 000
    K251798 000
    K260462 000