DEVICE: CPI RAD VISION (00885310000021)

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Device Identifier (DI) Information

CPI RAD VISION
VZW2944M9

Communications & Power Industries Canada Inc
00885310000021
GS1
1
The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that is designed to capture digital radiographic X-ray images in hospitals and clinics. Generator controls for setting exposure factors and techniques are included along with the image acquisition functions. Images are automatically pre-processed during acquisition, and further image processing may be applied after the images have been acquired or stored. This allows the image(s) to be enhanced to improve the visualization of anatomical details. Images may be stored on the built-in hard disk, on optical disc (CD/DVD-R/RW), or on a DICOM 3.0 compliant network storage device. This is a non-invasive device, designed to image the major systems of the body: Skull, neck, chest, abdomen, pelvis, and extremities. It is not intended for mammographic, fluoroscopic, and / or angiographic applications. The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico 100 X-ray generators.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Stationary basic diagnostic x-ray system, digital An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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FDA Product Code

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Product Code Product Code Name
KPR System, X-Ray, Stationary
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 06, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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