(274 days)
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.