Duns Number:021677872
Device Description: The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, trans The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats.
Catalog Number
-
Brand Name
Intuition
Version/Model Number
Intuition Server
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K012086,K121916,K131447
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
0654b499-936d-4a38-85e3-f5ca50f75acb
Public Version Date
August 18, 2021
Public Version Number
3
DI Record Publish Date
November 24, 2020
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |