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510(k) Data Aggregation

    K Number
    K020353
    Device Name
    OMNIA X/XS ULTRASOUND SYSTEM
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-02-13

    (9 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K902142,K002002,K981626,K980557,K981528,K001400,K945773
    Why did this record match?
    Device Name :

    OMNIA X/XS ULTRASOUND SYSTEM

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

    The Omnia X/XS ultrasound imaging system is intended for the following applications: General The Ommal XIXO ultraoberative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Kaulology, Abdominal, Intraoporative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    The system also provides for the measurement of anatomical structures and for analysis THE System also provide information that is used for clinical diagnosis purposes.

    Device Description

    The Omnia X/XS is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

    AI/ML Overview

    The provided document is a 510(k) Summary for the Siemens Omnia X/XS Diagnostic Ultrasound System, dated December 19, 2001. It outlines the device description, intended uses, and technological comparison to predicate devices for regulatory clearance.

    This document does not contain information about acceptance criteria or specific studies showing device performance against such criteria. The "Indications for Use Form" (Attachments 4-20) lists the clinical applications each transducer is intended for and the available modes of operation, indicating whether these are "new" (N), "previously cleared" (P), or "added under Appendix E" (E) applications. However, these forms do not provide quantitative performance metrics, sample sizes, ground truth establishment, or details about study methodologies.

    Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory classification and intended use rather than detailed performance study results.

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