Device Dossier
smart-sync - Synchronizer, MRI system
Device Dossier for smart-sync - Synchronizer, MRI system (Synchronizer, MRI system, Class IIa, sponsor LSR Healthcare). ARTG record, intended purpose,…
- GMDN category: Synchronizer, MRI system
Intended purpose
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 and pediatric MR examinations. smart-sync is not intended to monitor any physiological parameters. The acquired MR images and/or spectra and the physiological parameters derived from these images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.