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510(k) Data Aggregation

    K Number
    K061437
    Device Name
    SIGMA 5000 SERIES, IMAGIC
    Manufacturer
    KONTRON MEDICAL SYSTEMS SAS
    Date Cleared
    2006-06-14

    (21 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K050099,K053084,K002239
    Predicate For
    K081919
    Why did this record match?
    Reference Devices :

    K050099, K053084

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

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

    Clinical ApplicationMode of Operation
    FetalB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    AbdominalB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    PediatricB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Small organs (Thyroid, Breast, Testicle)B, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Adult CephalicB, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    CardiacB, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    TransesophagealB, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    TransrectalB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    TransvaginalB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Peripheral VascularB, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Musculo-skeletal ConventionalB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Musculo-skeletal SuperficialB, M, PW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD)
    Device Description

    The Sigma 5000 series, Imagic is a medical diagnostic ultrasound imaging system. This submission adds an Adult Cephalic (Adult Transcranial) indication for use to the system, which was previously cleared with other diagnostic ultrasound investigations including Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes several transducers for use with the system.

    AI/ML Overview

    I am unable to provide a description of the acceptance criteria and study proving device performance because the provided text is a premarket notification for an ultrasound system, not a study report. It states that clinical tests are "not required" for the device as it uses the "same technology and principles as existing devices", and thus does not contain the information needed to answer the request.

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