Duns Number:069190036
Device Description: The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Po The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is used to wirelessly send images from a video source such as a C-Arm to the Radlink GPS or GPS Tablet. The Radlink Wireless C-Arm Kit is a computer system that accepts video signals from BNC, VGA, or DVI connections and converts these signals into an image file, which is then sent wirelessly to a Radlink GPS or GPS Tablet.
Catalog Number
-
Brand Name
Radlink Wireless C-Arm Kit
Version/Model Number
C-Arm Kit
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMD
Product Code Name
System, Digital Image Communications, Radiological
Public Device Record Key
072ef831-daff-49ca-a4b9-977d733e4439
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 21, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |