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U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: fetal/obstetric, gynecological, abdominal, pediatric, small organ, trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology, and musculoskeletal (both conventional and superficial).

The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals (physician, sonographer, etc.) for diagnostic ultrasound imaging and fluid flow analysis of the human body. Utilizing curved, linear, phased array, and endocavitary probes, the U-Lite allows for a wide range of clinical applications: Fetal/obstetric, gynecological, abdominal, pediatric, small organ, transvaginal, trans-rectal, cardiac, peripheral vascular, and musculoskeletal.

U-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and to display the data as B Mode, M Mode, Color Mode, Power Doppler imaging, and Pulse Wave Doppler spectrum. The U-Lite device utilizes a standard range of probes, including curved array (convex), linear array, phased array (sector), and endocavitary transducers.

The handheld U-Lite tablet's display is a high-resolution 7 inch color LED screen, and the controls are intuitive and easy to use. Controls are touch-activated - there are no knobs or switches. The U-Lite is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.

The provided document mentions performance data relating to safety standards for the U-Lite device, but does not describe an acceptance criteria and study proving a device's clinical performance.

Specifically, the "Performance Data" section on page 9 states:
"The device has been evaluated for acoustic output, biocompatibility, as well as for thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to applicable medical device safety standards. The U-Lite complies with voluntary standards:

• IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety
• IEC/EN 60601-1-1 Safety Requirements for Medical Electrical Systems
• IEC/EN 60601-1-2 Amendment A1:2006, General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
• IEC/EN 60601-1-6 General Requirements for Safety Collateral Standard: Usability
• IEC/EN 60601-2-37 Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment"

This indicates that the device meets safety and electrical standards, but provides no information about performance criteria related to diagnostic accuracy, image quality, or other clinical measures. The document primarily focuses on establishing "substantial equivalence" to a predicate device (GE Venue 50) based on intended use and technological characteristics, not a separate clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the requested information.

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