BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LungVision System

    DI: 07290017652030 · Model: Core · BODY VISION MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LungVision System
    Primary DI
    07290017652030
    Version / Model
    Core
    Catalog Number
    LV1055001
    Company Name
    BODY VISION MEDICAL LTD
    Labeler DUNS
    600280073
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-29
    Public Version
    2
    Public Version Date
    2022-05-27
    Public Version Status
    Update
    Public Device Record Key
    83ca6b2f-89cf-4586-8027-718d0526d54e

    Device Description

    The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.

    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
    Yes
    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    58042 Virtual bronchoscopic navigation PACS software

    Identifiers

    Type ID
    Primary 07290017652030