BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

    K Number: K242239 · Decision Aug 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    17

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
    K Number
    K242239
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gentuity, LLC
    Date Received
    July 30, 2024
    Decision Date
    August 16, 2024
    Product Code
    NQQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQQ System, Imaging, Optical Coherence Tomography (Oct)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQQ), ordered by most recent decision date.

    OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIA Console (542-7)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HyperVue™ Imaging System - Integrated

    FDA 510(k)
    FDA Class 2 ·Radiology

    deepLive (OSP12 + DMS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HyperVue™ Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPUSWAVE Dual Sensor Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Gentuity, LLC

    K Number Device Name
    K242966 Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
    K230620 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
    K192922 Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter