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The Versana Premier is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Premier clinical applications include : Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vasculoskeletal Conventional, Musculosketal Superficial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include : B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.

The Versana Premier is a general purpose, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.

The provided text details a 510(k) premarket notification for the "Versana Premier" diagnostic ultrasound system. However, it explicitly states, "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them because such a study was not required or conducted for this specific submission to demonstrate substantial equivalence.

The document focuses on non-clinical tests to demonstrate safety and compliance with standards, and a comparison to predicate devices, rather than a clinical study with acceptance criteria.

If the request is based on the assumption that a clinical study was performed, that assumption is incorrect according to the provided text.

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