LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191678
    Device Name
    IP Converter
    Manufacturer
    Sony Electronics Inc.
    Date Cleared
    2020-01-10

    (200 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K161122
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sony IP Converter's (PC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time. The IPC can send medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room. The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

    Device Description

    The NU-IP3T/NU-IP3R IP converters are devices for the transmission/reception of 4K or HD images over a network with low latency from devices equipped with 3G-SDI, HDMI, Display Port, or DVI image outputs. Connecting multiple IP converters via a network switch allows you to construct a network video transmission system for medical procedures.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Sony IP Converter NU-IP3T and NU-IP3R. It states that no clinical study was included in this submission (Section 9, page 6). Therefore, the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria cannot be extracted from this document, as such a study was not performed or submitted.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (Sony IP Converter NU-IP40S) through technological characteristics and non-clinical performance data.

    Below, I am providing the information that explicitly states why a clinical study was not included, rather than attempting to infer or fabricate acceptance criteria and study details.

    Information on Clinical Performance Data:

    • Clinical Performance Data: "No clinical study is included in this submission." (Section 9, page 6)

    Therefore, all other requested points about acceptance criteria, reported performance, sample sizes, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone performance are not present in this document as they relate to a clinical study that was explicitly not included.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1