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510(k) Data Aggregation

    K Number
    K023440
    Device Name
    PHILIPS DIGITAL IMAGING OPTION RELEASE 1
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Date Cleared
    2002-10-30

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K920793
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Digital Imaging option release 1 is intended to assist physicians for diagnostic purposes and is required for interventional procedures, providing digital functionality as Last Image Hold, Digital Subtraction and contains a user interface for viewing, reviewing and processing digital images. The Digital Imaging option release 1 includes the following features, such as :

      1. Providing Digital Acquisition or Fluoroscopy for Philips RF systems.
      1. Diagnostic and/or Interventional applications.
      1. Live subtracted acquisition and fluoroscopy for vascular applications.
      1. Single or multiple images can be acquired and reviewed.
      1. Sending digital images to printer, external workstations for post processing and reconstructions, PACS.
    Device Description

    The Digital Imaging is an option to the RF-Diagnost Eleva system family, comprising of an image processing subsystem that consists of digital imaging hardware & software. It receives digital images from the CCD camera in the RF-Diagnost Eleva system and is intended to be placed in the examination room.
    The MultiDiagnost Eleva system is an X-ray systems for RF diagnostic and interventional vascular procedures. The Philips MultiDiagnost features a remote controlled C-arm stand that can be configured with a 38 cm Image Intensifier.
    The Digital Imaging for the MultiDiagnost Eleva system allows the user to acquire digital images to be postprocessed, and reviewed on the examination monitor. The progressive display black and white output signal is suitable for CRT or LCD monitor types. The (RIS) patient data provided by the system controller can be merged with the images.

    AI/ML Overview

    This Philips Digital Imaging option release 1 is not a medical device that utilizes AI. This device is an image processing subsystem, which is intended to be placed in an examination room and receives digital images from a CCD camera in the RF-Diagnost Eleva system. The device's features include digital acquisition, live subtracted acquisition and fluoroscopy, and the ability to send images to a printer, external workstations, or PACS. Therefore, the questions related to AI/ML device performance validation are not applicable.

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