Identity
- Trade Name
- SyncBox FDA UDI
- Generic Name
- MRI system synchronizer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SB 3.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042054034 FDA UDI
- 510(k) Number
- K092253 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- MRI system synchronizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
SyncBox by Nordicneurolab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092253 also covers:
- Coil Mounted Display — Nordicneurolab
- CommunicationConsole — Nordicneurolab
- Eye Tracker Camera — Nordicneurolab
- Fiberlink transmitter — Nordicneurolab
- Headphones — Nordicneurolab
- Inroom Viewing Device — Nordicneurolab
- LCD Power Supply — Nordicneurolab
- LCD Power Supply — Nordicneurolab
- Shielded Interface Unit — Nordicneurolab
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nordicneurolab
Sources (1)
- FDA UDI 71434610-bfbc-4722-836a-bc9578b6d9ae 36 fields · synced May 31, 2026