BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    INSIGHTEC, LTD.

    Reg #: 9615058 · FEI: 3003105983 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    INSIGHTEC, LTD.
    Registration Number
    9615058
    FEI Number
    3003105983
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 NAHUM HETH ST.
    City
    TIRAT CARMEL Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K212150
    PMA Number
    P150038

    Owner / Operator

    Firm Name
    INSIGHTEC
    Operator Number
    9039651
    Address
    4851 LBJ Freeway, Suite 300
    City
    Dallas
    State
    TX
    Postal Code
    75244
    Country
    US
    Correspondent
    Lidar - Dvir

    US Agent

    Business Name
    Insightec
    Contact Name
    Lidar Dvir
    Address
    4851 Lbj Fwy Ste 300
    City
    Dallas
    State
    TX
    ZIP
    75244
    Country
    US
    Email
    [email protected]
    Phone
    214 8464320

    Products

    Device Name Product Code
    High Intensity Ultrasound System For Prostate Tissue Ablation PLP
    Mr-Guided Focused Ultrasound System POH
    Ultrasound, Hyperthermia, Cancer Treatment LSY
    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided NRZ

    Proprietary Names

    Exablate Prostate System Exablate Neuro Exablate PRIME ExAblate P110039

    Establishment Types

    Manufacture Medical Device