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510(k) Data Aggregation

    K Number
    K022567
    Device Name
    SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    ACUSON CORP.
    Date Cleared
    2002-08-13

    (11 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K973767,K992580,K992631,K002807,K991805,K002470
    Why did this record match?
    Reference Devices :

    K973767, K992580, K992631, K002807, K991805, K002470

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

    The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications.

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

    The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

    Device Description

    The Sequoia 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) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

    AI/ML Overview

    This document is a 510(k) Summary for the Acuson Sequoia Diagnostic Ultrasound System Signature II. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

    The 510(k) summary focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through adherence to safety standards and a comparison of technological features. It does not include performance metrics or a study demonstrating the device's efficacy or accuracy against specific acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory compliance for market clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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