Duns Number:671280238
Device Description: NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which contr NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Catalog Number
-
Brand Name
nordicAktiva
Version/Model Number
1.3
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
K092253
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
9f8f73dd-99d7-4a2d-a4fb-82b0a190ce3a
Public Version Date
June 02, 2020
Public Version Number
5
DI Record Publish Date
May 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |