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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
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K000474,K982862,K955092
    Why did this record match?
    Applicant Name (Manufacturer) :

    AETMED, S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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
    AI/ML Overview

    The provided text is a 510(k) summary for the AETmed Image Processing Software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

    Therefore, many of the requested items cannot be extracted directly from this document. The document primarily uses a Substantial Equivalence Comparison Chart (Table 1) to compare the features of the AETmed Image Processing Software with predicate devices. This comparison implicitly serves as the "study" for acceptance, indicating that if the new device has comparable or superior features to legally marketed predicate devices, it is considered substantially equivalent.

    Here's a breakdown of what can and cannot be answered based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in the traditional sense of measurable performance metrics with thresholds. Instead, it demonstrates "substantial equivalence" by comparing device features with legally marketed predicate devices. The "reported device performance" is implicitly shown through this feature comparison.

    FeatureAcceptance Criteria (Implied: Substantially Equivalent to Predicates)Reported Device Performance (AETmed Image Processing Software)
    ManufacturerAETmedAETmed
    Classification892.2050; Class II892.2050; Class II
    Intended UseComparable to predicates for medical image capture, viewing, processing, archiving, and communication for cardiac catheterization, echocardiography, and general radiological studies.Capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images (cardiac catheterization, echo-cardiography, general radiological studies). Similar to predicates.
    Graphical User InterfaceYesYes (Matches predicates)
    PlatformPCPC (Matches predicates)
    Operating SystemWindows NT, Windows 2000 (at least Windows NT as per predicates)Windows NT, Windows 2000 (Broader than one predicate, similar to another)
    Display ResolutionUp to 2048x2560 (Comparable to leading predicates)Up to 2048x2560 (Matches leading predicates)
    Gray scale resolutionFrom 8 bits, 256 levels to 24 bits true color (Comparable to leading predicates)From 8 bits, 256 levels to 24 bits true color (Matches leading predicates)
    Multi-monitor supportYesYes (Matches predicates)
    Patient DemographicsYesYes (Matches predicates)
    NetworkingTCP/IPTCP/IP (Matches predicates)
    Image CommunicationDICOM CompliantDICOM Compliant (Matches predicates)
    DICOM CompliantYesYes (Matches predicates)
    Image CompressionJPEG loss-less (at least)JPEG loss-less (Comparable/matches some predicates)
    Video signals grabbingYesYes (Matches predicates)
    Analogic Video Input format525, 625, 1023, 1049, 1249; interlaced or progressive (Comparable to predicates)525, 625, 1023, 1049, 1249; interlaced or progressive (Matches one predicate, exceeds another)
    Analogic Video Input rate
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