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The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest: Ophthalmic; Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other.
Exam Type, Means of Access: Transesophageal; Transrectal; Transvaginal; Transuretheral; Intraoperative; Intraoperative Neurological; Intravascular; Laparoscopic.

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general-purpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

The provided 510(k) summary for the GE Healthcare Voluson P6, Voluson P8 Ultrasound System states explicitly:

"The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence."

Therefore, no acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study results are detailed in this document. The submission relies on non-clinical tests and substantial equivalence to predicate devices (K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System and K113758 Voluson E6E8E8ExpertE10) to demonstrate safety and effectiveness.

The document lists conformity to applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It also mentions quality assurance measures during development, such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, and safety).

Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study results as this device did not require clinical studies for its 510(k) submission.

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