DEVICE: SyncBox (07090042054034)
Device Identifier (DI) Information
SyncBox
SB 3.0
Not in Commercial Distribution
Nordicneurolab AS
SB 3.0
Not in Commercial Distribution
Nordicneurolab AS
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36005 | MRI system synchronizer |
A physiological monitoring unit used as a component of a diagnostic magnetic resonance imaging (MRI) system, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic MRI applications. It is sometimes referred to as a gated imaging accessory or trigger.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LNH | System, Nuclear Magnetic Resonance Imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K092253 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
71434610-bfbc-4722-836a-bc9578b6d9ae
June 02, 2020
6
October 24, 2016
June 02, 2020
6
October 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4755707095
ProductSolutions@nordicneurolab.com
ProductSolutions@nordicneurolab.com