northh medical GmbH

Address:Roentgenstrasse 24,Hamburg,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Nuclear Magnetic Resonance Imaging (LNH) (1)

Premarket Exempt

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smart-sync - 04260675390011 Catalog Number : P01-SB-01

Device Description : smart-sync is an MRI-compatible Doppler ultrasound system that determines the ca 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 Class : 2

Duns Number: 314359601

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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