Duns Number:307332705
Device Description: The Intelli-C X-ray device is a multi-purpose - also sometimes known as a universal C-arm The Intelli-C X-ray device is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies.
Catalog Number
-
Brand Name
Intelli-C Right Side Suspended Table
Version/Model Number
03400000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173631
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
15319798-6d05-4d98-b363-630491b9bc35
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 17, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |