Duns Number:021677872
Device Description: Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-foo Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Catalog Number
-
Brand Name
Eureka
Version/Model Number
Eureka AI Results Explorer
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"
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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
-
Product Code
LMD
Product Code Name
System, Digital Image Communications, Radiological
Public Device Record Key
211e716d-be36-435e-86b4-5d6ef0512d5d
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 |