BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    EXACT IMAGING, INC.

    Reg #: 3012402886 · FEI: 3012402886 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    EXACT IMAGING, INC.
    Registration Number
    3012402886
    FEI Number
    3012402886
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7676 Woodbine Avenue, Unit 15
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K990175

    Owner / Operator

    Firm Name
    Exact Imaging, Inc.
    Operator Number
    10053728
    Address
    7676 Woodbine Avenue, Unit 15
    City
    Markham
    State
    Ontario
    Postal Code
    L3R 2N2
    Country
    CA
    Correspondent
    Randy AuCoin

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Applicator, Radionuclide, Manual IWJ
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    SHEATHES (NON-LATEX), STERILE Transperineal Transducer Cradle Transperineal Reusable Template Transperineal Stepper Transperineal Disposable Template EV29L Sterile Transperineal Needle Guide EV29L Sterile Transperineal Needle Guide Kit EV5C Abdominal Transducer EV29L High Resolution Side-Fire Transducer ExactVu High Resolution Micro-Ultrasound System EV9C Transrectal End-Fire Transducer EV29L Sterile Transrectal Needle Guide Kit EV29L Sterile Transrectal Needle Guide EV29L Reusable Transrectal Needle Guide (16 & 18 GA) EV29L Sterile Biopsy Needle Guide EV29L High Resolution Transrectal Side-Fire Transducer EV29L Reusable Needle Guide ExactVu™ High Resolution Micro-Ultrasound System EV29L High Resolution Transrectal Side-Fire transducer EV29L Non-Sterile Reusable Transrectal Needle Guides

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device