Duns Number:671280238
Device Description: SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directly to the M SynkBox is part of NordicNeuroLab’s fMRI System.The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it’s forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings.
Catalog Number
-
Brand Name
SyncBox
Version/Model Number
SB 3.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
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
71434610-bfbc-4722-836a-bc9578b6d9ae
Public Version Date
June 02, 2020
Public Version Number
6
DI Record Publish Date
October 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |