BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Phase Array

    DI: 00860000784849 · Model: LQ-A3S1 · LINKQUEST INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Phase Array
    Primary DI
    00860000784849
    Version / Model
    LQ-A3S1
    Company Name
    LINKQUEST INC.
    Labeler DUNS
    144772626
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-01
    Public Version
    1
    Public Version Date
    2019-06-10
    Public Version Status
    New
    Public Device Record Key
    6d0a576d-4a2a-424f-8c80-e00f387d99a0

    Device Description

    A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

    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
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    40768 Extracorporeal ultrasound imaging transducer, hand-held

    Identifiers

    Type ID
    Primary 00860000784849

    Customer Contacts

    Phone
    8586239900
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K172059 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    -15 – 50 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity