Device Dossier

Radiology DICOM image processing application software

Device Dossier for Radiology DICOM image processing application software (Radiology DICOM image processing application software, Class IIb, sponsor…

Intended purpose

Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyse and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers and radiologists to generate a report for review and approval by a qualified cardiologist with echocardiography subspecialty certification. Any generated report should not be used for clinical decision making before such review and approval. Us2.v2 is indicated for use in adult patients.

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