KOSMOS
EchoNous, Inc.KOSMOS is a handheld diagnostic ultrasound system by EchoNous, Inc. that integrates ultrasound imaging, electrocardiogram (ECG), and digital auscultation in one device. It is designed for clinical assessment of cardiac, pulmonary, abdominal, and vascular systems by providing synchronized images, sounds, and waveforms. This facilitates enhanced diagnosis and guided interventions for healthcare professionals in various clinical settings.
Intended Use
KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
Technology
KOSMOS integrates a tablet and a probe with an ultrasound transducer, sealed microphones for auscultation, and ECG acquisition cable. It supports B-mode, M-mode, Color Doppler, combined modes, and harmonic imaging. It acquires synchronized ultrasound images, ECG, and auscultation sounds displayed and stored on the tablet, enabling multi-modal clinical assessment.
Performance
KOSMOS was tested to comply with FDA recognized standards covering electrical safety, ECG monitoring, usability, ultrasound performance, acoustic output, software lifecycle, and biocompatibility. Verification and validation confirm specs are met and substantially equivalent to predicate devices. Clinical performance data was not required for substantial equivalence.
Predicate Devices
No predicate devices specified
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