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510(k) Data Aggregation

    K Number
    K994054
    Device Name
    ISSA PHAROS
    Manufacturer
    VAMS TEC, D.O.O.
    Date Cleared
    2000-02-14

    (76 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K961023
    Why did this record match?
    Device Name :

    ISSA PHAROS

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

    Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.

    Device Description

    The ISSA™ Imaging and PHAROS Communication Products is a lightly integrated package of software elements designed to provide:

    • DICOM compliant telemedicine viewer interface
    • 2D viewer of all stored medical images .
    • . Telemedicine communication system
      In general terms, Issa PHAROS contains two software applications, Issa and Pharos. Both belong to the group of software produsts for medical image management and manipulations are designed to fit equaly to small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments. Image management and manipulation here means acquisition, archival, processing and transmission or distribution.
    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the ISSA™ Imaging and PHAROS Communication Products. This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

    The document states:

    • "There are no applicable FDA mandated performance standards for this device."
    • "The software described in the submission was developed, tested and validated in accordance with written Verification and Validation procedures."
    • "No known hazardous procedures were detected during verification and testing that would be the consequence of software operation."

    This indicates that while internal verification and validation were performed, no specific performance metrics or clinical study results are presented in this public summary to address the questions asked. The document is primarily a regulatory filing for substantial equivalence based on design and intended use, not a detailed technical performance report.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, or ground truth based on the provided text.

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