LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252919

    Validate with FDA (Live)

    Device Name
    IDENTIFY (5.0)
    Manufacturer
    Varian Medical Systems, Inc.
    Date Cleared
    2025-12-16

    (95 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    18 - 999
    Reference & Predicate Devices
    K242957
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for monitoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.

    Device Description

    IDENTIFY uses surface guidance technology to monitor patient motion during radiotherapy treatment simulation and delivery. Its high precision SGRT cameras support:

    • Positioning of the patient for treatment delivery
    • Monitoring of the patient position during treatment delivery
    • Respiratory motion management during simulation and treatment delivery
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1