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510(k) Data Aggregation

    K Number
    K961229
    Device Name
    HR12000 ULTRASOUND SYSTEM
    Date Cleared
    1997-05-29

    (426 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL ULTRASOUND CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy. Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
    Device Description
    HRI 2000 Ultrasound System
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