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510(k) Data Aggregation

    K Number
    K021497

    Validate with FDA (Live)

    Device Name
    CYPRESS ULTRASOUND SYSTEM
    Manufacturer
    ACUSON CORP.
    Date Cleared
    2002-07-09

    (61 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K010950,K982800,K991872
    Predicate For
    K022896,K042055,K052331,K060992,K080234
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications.

    Device Description

    The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

    AI/ML Overview

    There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the Acuson Cypress Ultrasound System, focusing on substantial equivalence to predicate devices and listing intended uses for new transducers. It does not contain performance metrics, study designs, or details on how the device's accuracy or effectiveness was evaluated against specific criteria.

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