Duns Number:863358955
Device Description: SKANMOBILE DR is a digital radiographic system designed for superior image quality featuri SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detectorand operator console for digital imaging integrated with high frequency generator.
Catalog Number
-
Brand Name
SKANMOBILE DR
Version/Model Number
303-000018-16
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
7d18cb9e-69e3-4bf0-837a-afe80b11f0a2
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 |