HS40 Diagnostic Ultrasound System
Samsung Medison CO., LTD.The HS40 Diagnostic Ultrasound System by Samsung Medison is a versatile ultrasound imaging device designed to capture and display detailed ultrasound images using various modes such as 2D, Doppler, and 3D/4D imaging. It supports a wide range of clinical uses from obstetrics and gynecology to cardiac and musculoskeletal imaging, helping healthcare professionals diagnose conditions and analyze anatomical structures safely and effectively.
Intended Use
The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids for clinical diagnosis across multiple anatomical areas including fetal/obstetrics, abdominal, gynecology, pediatric, small organ, cephalic, musculoskeletal, urology, cardiac, and peripheral vessel.
Technology
The HS40 system is a mobile, software-controlled diagnostic ultrasound device that acquires ultrasound data and displays it in multiple modes including 2D, M mode, Color and Power Doppler, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, Elastoscan, and 3D/4D imaging. It employs fundamental ultrasound technology with additional features like NerveTrack software and new transducers, while ensuring safety via compliance with FDA recognized standards such as IEC 60601 and ISO 10993-1.
Performance
The device underwent non-clinical testing including acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness, and safety testing for thermal, electrical, electromagnetic, and mechanical hazards. It complies with FDA recognized standards IEC 60601, ISO 10993-1, ISO 14971, and NEMA UD 2-2004. Clinical testing was not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/11/2021
3 months - 2
FDA Approval
5/13/2021
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