SyncBox

GUDID 07090042054058

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.

Nordicneurolab AS

MRI system synchronizer

• Primary Device ID: 07090042054058
• NIH Device Record Key: 3cd11c83-cb08-48f4-b81d-4510ffeeb0e6
• Commercial Distribution Discontinuation: 2019-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SyncBox
• Version Model Number: SB- 3.2
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042054058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092253

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [SyncBox]

• 07090042054034: SynkBox is part of NordicNeuroLab’s fMRI System. The SyncBox is connected directly to the MRI
• 07090042054058: SynkBox is part of NordicNeuroLab’s fMRI System. The SyncBox is connected directly to the MRI