Duns Number:428658934
Device Description: It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector.
Catalog Number
-
Brand Name
CLISIS SYSTEMS
Version/Model Number
CLISIS EXEL DRF
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
KXJ
Product Code Name
Table, Radiologic
Public Device Record Key
deffbe5a-1ed3-49f0-9676-45a5618d2faf
Public Version Date
December 23, 2021
Public Version Number
4
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 |