BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENTUITY, LLC

    Reg #: 3011578544 · FEI: 3011578544 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GENTUITY, LLC
    Registration Number
    3011578544
    FEI Number
    3011578544
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    142 North Road, Suite G
    City
    Sudbury
    State
    MA
    ZIP
    01776
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242966

    Owner / Operator

    Firm Name
    Gentuity, LLC
    Operator Number
    10073861
    Address
    142 North Road, Suite G
    City
    Sudbury
    State
    MA
    Postal Code
    01776
    Country
    US
    Correspondent
    Edwin Rule

    Products

    Device Name Product Code
    System, Imaging, Optical Coherence Tomography (Oct) NQQ
    Catheter, Intravascular, Diagnostic DQO
    Optical Coherence Tomography, Intravascular Catheter ORD

    Proprietary Names

    HF-OCT Imaging System with Vis-Rx Prime Micro-Imaging Catheter HF-OCT Imaging System with StentX Software Vis-Rx® Micro-Imaging Catheter Gentuity® HF-OCT Imaging System Gentuity HF-OCT Imaging System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198