CPI RAD VISION

GUDID 00885310000021

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.

Communications & Power Industries Canada Inc

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00885310000021
• NIH Device Record Key: e0b5e150-058a-4845-abbc-ecc1b63236ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPI RAD VISION
• Version Model Number: VZW2944M9
• Company DUNS: 203144092
• Company Name: Communications & Power Industries Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885310000021 [Primary]

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-06

Devices Manufactured by Communications & Power Industries Canada Inc

• 00885310000038 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 400V
• 00885310000045 - CMP200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 480V
• 00885310000052 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 50kW, 208/230V,3PH.
• 00885310000069 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 65kW, 400V
• 00885310000076 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 65kW, 480V
• 00885310000083 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 80kW, 400V
• 00885310000090 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic, CMP200, RAD, 80kW, 480V
• 00885310000106 - CMP 200 DR: 2020-10-14 Generator, High-Voltage, X-Ray, Diagnostic ,CMP200, RAD, 40kW, 400V