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510(k) Data Aggregation

    K Number
    K173981
    Device Name
    ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
    Manufacturer
    Siemens Medical Solutions USA, Inc. Ultrasound Group
    Date Cleared
    2018-02-02

    (35 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Medical Solutions USA, Inc. Ultrasound Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
    Device Description
    The ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their functions are to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaqing on a Flat Panel Display.
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    K Number
    K163635
    Device Name
    ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
    Manufacturer
    Siemens Medical Solutions USA, Inc. Ultrasound Group
    Date Cleared
    2017-01-12

    (21 days)

    Product Code
    IYN, ITX, IYO, OBJ
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Medical Solutions USA, Inc. Ultrasound Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging”. The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
    Device Description
    The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound svstems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The 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 and 3D/4D Imaging on a Flat Panel Display.
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