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510(k) Data Aggregation

    K Number
    K022940
    Device Name
    IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
    Manufacturer
    INTELLIGENT IMAGES SRL
    Date Cleared
    2002-10-11

    (37 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K011582
    Why did this record match?
    Device Name :

    IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

    In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.

    Device Description

    In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.

    In-Vision View with Measurements Module provides an effective solution for physicians and interventional labs to review JOMED's In-Vision Gold digital IVUS DICOM video loops on a desktop PC or notebook. In addition, video loops and still frames can be exported to PowerPoint presentations for conferences, in-hospital training and lectures.

    AI/ML Overview

    This document is a 510(k) summary for the In-Vision View with Measurements Module, a software device for processing medical IVUS images. It confirms the device's substantial equivalence to a predicate device, but does NOT contain information regarding acceptance criteria, study details, or ground truth establishment. The provided text primarily focuses on device description, intended use, and substantial equivalence to a predicate device (QCU ANALYTICAL SOFTWARE PACKAGE K011582).

    Therefore, I cannot fulfill your request for the specific details outlined, as those details are not present in the provided text.

    Based on the provided text, the following information is available:

    • Device Name: In-Vision View with Measurements Module
    • Manufacturer: Intelligent Images S.r.l.
    • Predicate Device: QCU ANALYTICAL SOFTWARE PACKAGE (K011582) by MEDIS MEDICAL IMAGING SYSTEMS, B.V.
    • Intended Use: To be used by qualified medical professionals for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. It only supports JOMED DICOM files.
    • Classification Name: System, Image Processing
    • Classification Number: LLZ

    The document DOES NOT provide the following requested information:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance
    6. If a standalone performance study was done
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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