IR 14X17 Portable GOS Flat Panel Detector without USB (-R or -L)


Product Overview

IR 14X17 Portable GOS Flat Panel Detector without USB (
14X17 Portable GOS Flat Panel Detector without USB - PAN241


Device Description

An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 5.00
  • Handling Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MQB

    Device Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 892.1680

    Third Party Flag: Y

    Medical Specialty: RA


    Device Identifiers

    Device Id: 00817100020247

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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