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510(k) Data Aggregation
K Number
K212271Device Name
smart-sync
Manufacturer
Date Cleared
2022-02-04
(199 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
northh medical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
smart-sync is intended to generate a gating signal for MR scanners (1.5T and 3T) for motion compensation by detecting the heartbeat of a patient using Doppler ultrasound. Thus, smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary.
smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.
smart-sync is not intended to monitor any physiological parameters.
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.
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