Duns Number:863358955
Device Description: Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors,one for control / supervisory functions and another for man-machine/user interface. The technology incorporatesfeedback circuits to ensure accuracy & reproducibility of X-Ray output.
Catalog Number
-
Brand Name
SKANMOBILE
Version/Model Number
303-000018-3
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
K212940
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
714d6ac5-108b-4754-b043-c00c45dfd317
Public Version Date
April 29, 2022
Public Version Number
1
DI Record Publish Date
April 21, 2022
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 |