BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Simpleware Medical

    DI: 00860011545705 · Model: V-2024.06 - · SYNOPSYS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Simpleware Medical
    Primary DI
    00860011545705
    Version / Model
    V-2024.06 -
    Company Name
    SYNOPSYS, INC.
    Labeler DUNS
    161499579
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-10
    Public Version
    4
    Public Version Date
    2026-01-26
    Public Version Status
    Update
    Public Device Record Key
    c66c8473-59a2-48f8-9d92-88ef0aed4267

    Device Description

    Simpleware Medical image processing. Applicable software versions (UDI-PI) (01)00860011545705(8012)V-2024.06 (01)00860011545705(8012)W-2024.12 (01)00860011545705(8012)X-2025.06 (01)00860011545705(8012)Y-2026.03

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00860011545705

    Customer Contacts

    Phone
    +4401392642635
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K203195 000