HS40 Diagnostic Ultrasound System

The HS40 Diagnostic Ultrasound System is a versatile, software-controlled imaging platform designed to acquire and analyze ultrasound data across a broad spectrum of clinical applications using multiple advanced imaging modes. It employs established ultrasonic principles and introduces new features like Nerve Track software and the CA4-10M transducer to enhance diagnostic capabilities for healthcare professionals.

The HS40 Diagnostic Ultrasound System, manufactured by Samsung Medison CO., LTD., is a general-purpose, mobile, software-controlled device designed to acquire ultrasound data and display it in various modes for diagnostic purposes. Its primary function is to obtain ultrasound images and analyze body fluids, supporting a wide range of clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Cephalic (Neonatal and Adult), Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac (Adult and Pediatric), and Peripheral vessel imaging. The system is intended for use by appropriately trained healthcare professionals in settings such as hospitals, private practices, and clinics for clinical diagnosis. The HS40 system operates using fundamental ultrasonic pulsed doppler and pulsed echo imaging technology, offering modes such as 2D, M mode, Color Doppler, Power Doppler, Pulsed Wave and Continuous Wave Doppler, Tissue Doppler Imaging/Wave, ElastoScan, and 3D/4D imaging. It allows for anatomical measurements and provides analysis packages to aid diagnosis. The system displays real-time acoustic output with mechanical and thermal indices for safety. This version of the HS40 introduces a new software feature called "Nerve Track" and a new transducer, the CA4-10M. Non-clinical testing confirmed its conformity with applicable standards for acoustic output, biocompatibility, software function, cleaning, disinfection, and electrical, thermal, electromagnetic, and mechanical safety.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific advancements or clinical benefits does the new "Nerve Track" software feature offer compared to existing nerve visualization techniques in ultrasound?; How does the performance of the new CA4-10M transducer (e.g., resolution, penetration depth, bandwidth) compare to other transducers available for the HS40 system or similar systems, particularly for its intended applications?; Could you elaborate on the technical specifications and validation process for the ElastoScan mode on the HS40, particularly concerning its quantitative accuracy and reproducibility across different tissue types?; What are the specific improvements or changes in this version of the HS40 (K210426) compared to its primary predicate HS40 (K200339), beyond the Nerve Track feature and CA4-10M transducer?; Are there any published studies or white papers detailing the clinical utility or performance of the HS40 system, especially with the new Nerve Track feature or CA4-10M transducer, in any of its listed clinical applications?