AccessGUDID - DEVICE: CPI RAD VISION (00885310000021)

GUDID

Device Identifier (DI) Information

Brand Name: CPI RAD VISION
Version or Model: VZW2944M9
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Communications & Power Industries Canada Inc

Primary DI Number: 00885310000021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203144092 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37645	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0b5e150-058a-4845-abbc-ecc1b63236ad
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 06, 2017