Duns Number:863358955
Device Description: SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervent SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.
Catalog Number
-
Brand Name
Skan C Mobile C - Arm X - Ray system
Version/Model Number
F303-000187-2
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
K170946
Product Code
OWB
Product Code Name
Interventional Fluoroscopic X-Ray System
Public Device Record Key
76c05ccc-1d90-4e98-b4fb-b9b0b30b2542
Public Version Date
January 19, 2022
Public Version Number
2
DI Record Publish Date
January 21, 2019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |