V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

The Samsung Medison V-series Diagnostic Ultrasound Systems are designed to acquire and analyze ultrasound images and body fluids for a broad spectrum of clinical applications. Their marketability was established through a determination of substantial equivalence to existing devices, supported by comprehensive non-clinical testing covering various safety and performance standards.

Samsung Medison Co., Ltd. has received a determination of substantial equivalence for their V8, cV8, V7, cV7, V6, and cV6 Diagnostic Ultrasound Systems. This regulatory finding confirms that these systems are equivalent to other devices already on the market for their intended uses, thus permitting their commercialization provided they adhere to ongoing general regulatory requirements such as annual registration, device listing, good manufacturing practices, and accurate labeling. These diagnostic ultrasound systems and their associated probes are engineered to capture ultrasound images and analyze body fluids across a wide array of clinical disciplines, including but not limited to Fetal/Obstetrics, Abdominal, Gynecology, Cardiac, Musculoskeletal, and Peripheral Vessel imaging. They support diverse operational modes like 2D, Color Doppler, M mode, Pulsed Wave Doppler, and 3D/4D. The substantial equivalence was established by thoroughly comparing the proposed devices' intended use, imaging functionalities, technological attributes, and their safety and effectiveness against existing predicate devices, substantiated by extensive non-clinical testing covering critical aspects such as acoustic output, biocompatibility, software integrity, cleaning and disinfection protocols, and compliance with electrical, thermal, electromagnetic, and mechanical safety standards.

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. Given the broad range of clinical applications, what specific performance metrics were evaluated for each, and how do they quantitatively compare to the predicate devices?; Could the detailed non-clinical testing data, particularly for acoustic output, software performance, and cleaning/disinfection efficacy, be made available for further scientific review?; Are there any specific limitations or contraindications identified for particular operational modes (e.g., 3D/4D) across different patient populations, and how were these addressed in the evaluation?; What post-market surveillance plans are in place to continuously monitor the safety and effectiveness of these V-series systems in real-world clinical settings?; How does the image quality and diagnostic accuracy of the V-series systems quantitatively compare to established predicate devices, especially for challenging anatomical areas or specific pathologies?