smart-sync P01-SB-01

GUDID 04260675390035

smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of patients and synchronizes it with the MRI imaging. smart-sync can be used for the synchronization of the heartbeat both for fetuses and adults. The heartbeat of the patient is detected by positioning an ultrasound sensor above the patient’s heart. The ultrasound sensor is fixated with a flexible belt. The reflection of Doppler ultrasound signals is analyzed, and a trigger signal is derived for every heartbeat. smart-sync sends the Doppler ultrasound signal and the trigger signal (synchronization signal) to the MRI scanner utilizing a wireless connection.

northh medical GmbH

MRI system synchronizer

• Primary Device ID: 04260675390035
• NIH Device Record Key: 9987258f-192a-4add-9975-23db28cb0aa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: smart-sync
• Version Model Number: P01-SB-01 (LOT: 5)
• Catalog Number: P01-SB-01
• Company DUNS: 314359601
• Company Name: northh medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de
• Phone: +494023969451
• Email: support@northh.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260675390035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212271

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: 2025-08-06
• Device Publish Date: 2025-07-29

On-Brand Devices [smart-sync]

• 04260675390011: smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of p
• 04260675390028: smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of p
• 04260675390035: smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of p