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    K Number
    K081976
    Device Name
    IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
    Manufacturer
    AGFA HEALTHCARE CORPORATION
    Date Cleared
    2008-07-28

    (17 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040555,K043146
    Why did this record match?
    Device Name :

    IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

    The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images.

    The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

    Device Description

    IMPAX MA3000 is a diagnostic softcopy breast imaging workstation with diagnostic print capability.

    The following features are available:

    · Display and printing of regionally approved DICOM DR Digital Mammography Images

    (MG SOP class)

    · Display and printing of regionally approved DICOM CR Digital Mammography Images

    (CR SOP class)

    The Hardware configuration of Embrace™ will consist of the following:

    Dell Precision™ Workstation 650; System (Per Host Machine): Compaq xw6000

    Number & Details of CPU's 1 or 2 CPU's depending on configuration

    Hard Drive space: 40GB IDE

    CD-ROM: Yes

    Floppy: Yes

    Network interfaces: System comes with an integrated 10/100/1000 Ethernet adapter

    Power Supplies: Default

    Chassis: Tower

    Peripherals: Microsoft IntelliMouse or IntelliMouse Explorer; Keyboard

    Embrace™ will support the following monitors:

    • BARCO Mammography MeDis 5MP CRT monitor package MGD . 521M
    • . BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU)
    AI/ML Overview

    The provided text is a 510(k) summary for a PACS workstation and does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document describes the device name, classification, indications for use, and a comparison to predicate devices, focusing on substantial equivalence for regulatory approval. It does not include details on performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the requested study information.

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