Duns Number:069190036
Device Description: The Radlink Picture Archiving and Communication System (PACS) is an external server for st The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information.
Catalog Number
-
Brand Name
Radlink PACS
Version/Model Number
PACS-SW
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
ed193300-2b35-4a66-8bba-b7121c5477a8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 24, 2017
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 |