Duns Number:203144092
Device Description: The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system t The CPI RAD VISION digital imaging system is a full-featured radiographic imaging system that isdesigned to capture digital radiographic X-ray images in hospitals and clinics. Generator controlsfor 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 beapplied after the images have been acquired or stored. This allows the image(s) to be enhanced toimprove 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 3.0compliant 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 / orangiographic applications.The CPI RAD VISION digital imaging system is intended for use with CPI CMP 200 DR or Indico100 X-ray generators.
Catalog Number
-
Brand Name
CPI RAD VISION
Version/Model Number
VZW2944M9
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPR
Product Code Name
System, X-Ray, Stationary
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |