Duns Number:428658934
Device Description: The ceiling suspension is a radiographic X-ray tube suspension device that allows direct d The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital radiological diagnostic, pulmonary, skeletal and emergency.
Catalog Number
-
Brand Name
CLISIS SYSTEMS
Version/Model Number
KALOS
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
IYB
Product Code Name
Tube Mount, X-Ray, Diagnostic
Public Device Record Key
1a6375d4-6bc6-41a4-8a78-fdad437a46b7
Public Version Date
December 23, 2021
Public Version Number
6
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 |