Voluson™ Performance 16; Voluson™ Performance 18

The GE Medical Systems Voluson Performance 16 and 18 are general-purpose diagnostic ultrasound systems leveraging established imaging modalities and incorporating advanced AI and software features to provide comprehensive anatomical and physiological assessment. Their marketing determination is based on demonstrating substantial equivalence to existing devices through rigorous non-clinical testing, ensuring compliance with medical device safety standards for broad clinical applications.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC has secured marketing authorization for its Voluson Performance 16 and Voluson Performance 18 diagnostic ultrasound systems. These systems are designed for use by qualified healthcare professionals for general-purpose diagnostic imaging, measurement, display, and analysis across various parts of the human body and fluid. They support a wide range of clinical applications including Fetal/Obstetrics, Abdominal, Cardiac, Pediatric, and Small Organ imaging, incorporating diverse modes such as B-mode, M-mode, PW Doppler, Color Doppler, and advanced 3D/4D imaging capabilities. The determination for marketing was based on the systems' substantial equivalence to existing legally marketed devices, sharing fundamental scientific technology and similar imaging capabilities. Comprehensive non-clinical tests were conducted to evaluate aspects such as acoustic output, biocompatibility, cleaning and disinfection effectiveness, and electrical, thermal, electromagnetic, and mechanical safety, confirming adherence to applicable medical device safety standards. Furthermore, the Voluson Performance 16 and 18 integrate advanced AI and other sophisticated software features, like SonoPelvicFloor 3.0 and Voice Control, which have been successfully migrated from previously cleared models.

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 in image quality or diagnostic accuracy do the new AI features like SonoPelvicFloor 3.0 offer over previous Voluson models?; How do the acoustic output levels of the Voluson Performance 16 and 18 compare to established safety limits, especially for sensitive applications like fetal imaging?; Are there any specific patient populations or clinical scenarios where the 3D/4D imaging capabilities of these systems provide unique diagnostic advantages?; What post-market surveillance or real-world evidence collection is planned to assess the long-term clinical utility and safety of these systems, particularly concerning their advanced software features?; How does the user interface, particularly the Voice Control feature, enhance workflow efficiency and reduce cognitive load for clinicians during complex examinations?