smart-sync

Basic Information

• Brand Name: smart-sync
• Primary DI: 04260675390011
• Version / Model: P01-SB-01-02
• Catalog Number: P01-SB-01
• Company Name: northh medical GmbH
• Labeler DUNS: 314359601
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-24
• Public Version: 1
• Public Version Date: 2022-03-04
• Public Version Status: New
• Public Device Record Key: c9de77c9-9228-4fde-8f38-d7fef4a5ade2

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260675390011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212271	000