CDSCO UID IMP/MD/2022/000392_0cf16fe494d28207e0f1419f296cfb97_271b4e663e7c7882c6b20d859ae934ec

Ultrasound

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.·Device Class Class B·India CDSCO·Brand: i.e., Samsung S6, EchoNous Kosmos Ultrasound App

Registration details

UID: IMP/MD/2022/000392_0cf16fe494d28207e0f1419f296cfb97_271b4e663e7c7882c6b20d859ae934ec
Device class: Class B
Brand name: i.e., Samsung S6, EchoNous Kosmos Ultrasound App
License holder: M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.
Approving authority: CDSCO
Product information: KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) rhythms, and digital auscultation (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) sounds and waveforms. With respect to its ultrasound imaging capabilities, KOSMOS on Bridge is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed-Wave (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) Doppler, Tissue Doppler Imaging(i.e., Samsung S6, EchoNous Kosmos Ultrasound App), Continuous-Wave (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging. KOSMOS is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time. 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 ultrasound images. With respect to its ultrasound imaging capabilities, KOSMOS on Android is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/ Peripheral Vascular, Musculoskeletal and Image Guidance for Needle/ Catheter Placement (i.e., Samsung S6, EchoNous Kosmos Ultrasound App) Modes of operation: B-mode, M-mode, Color Doppler, combined modes of B+M and B+CD, and Harmonic Imaging KOSMOS is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time.