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The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

This 510(k) summary describes a diagnostic ultrasound system and the addition of a new probe. However, it does not contain any information about acceptance criteria or a study proving that the device meets such criteria for performance.

Therefore, I cannot provide the requested information, including the table and details about sample sizes, experts, adjudication, or standalone performance. The document focuses on safety standards, intended uses, and technological comparison to predicate devices, not on specific performance metrics or studies demonstrating compliance with such metrics using clinical data.

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