Duns Number:428658934
Device Description: The CLISIS SYSTEMS is a floor-mounted radiographic, fluoroscopic and linear tomographic sy The CLISIS SYSTEMS is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.
Catalog Number
-
Brand Name
CLISIS SYSTEMS
Version/Model Number
CLISIS SYSTEMS
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
K213081
Product Code
IZF
Product Code Name
System, X-Ray, Tomographic
Public Device Record Key
4ff8062d-95c1-4b75-be45-acb60b47d801
Public Version Date
January 31, 2022
Public Version Number
5
DI Record Publish Date
July 11, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |