Ultrasound(Kosmos Torso-One with Kosmos Bridge ) - India CDSCO Medical Device Registration

Ultrasound(Kosmos Torso-One with Kosmos Bridge ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000392_4c07b5f29af0a1e511a0225f8ec540c3_25f28cf44424dace5570b6b1f7f3e477. This device is marketed under the brand name i.e., Samsung S6, EchoNous Kosmos Ultrasound App. The license holder is M/S ASIA ACTUAL INDIA (OPC) PVT. LTD., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Ultrasound(Kosmos Torso-One with Kosmos Bridge )

UID: IMP/MD/2022/000392_4c07b5f29af0a1e511a0225f8ec540c3_25f28cf44424dace5570b6b1f7f3e477

Brand Name

i.e., Samsung S6, EchoNous Kosmos Ultrasound App

License Holder

M/S ASIA ACTUAL INDIA (OPC) PVT. LTD.

Device Class

Class B

Approving Authority

CDSCO

Product Information

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 is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: • Clinical applications: Cardiac, Thoracic/Lung, Abdominal, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement. • 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 paediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time