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510(k) Data Aggregation

    K Number
    K012093
    Device Name
    AETMED IMAGE PROCESSING SOFTWARE
    Manufacturer
    AETMED, S.P.A.
    Date Cleared
    2001-09-21

    (78 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AETMED, S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
    Device Description
    The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies. The Version 3.0 DICOMed Family Software System consists of the following components: - DICOMed DIG.IT image acquisition and CD recording station - DICOMed P@CS image archiving manager - DICOMed Review Cardio review workstation for cardiology - DICOMed Review diagnostic review workstation for radiology
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