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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac Adult & Pediatric; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other (Urology/Prostate); Transrectal; Transvaginal; Intraoperative.

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

This document is a 510(k) Premarket Notification Submission for the GE LOGIQ P9 and LOGIQ P7 ultrasound systems. It does not contain information about an AI/ML device or its performance criteria. Instead, it describes a conventional diagnostic ultrasound system and its equivalence to predicate devices, focusing on regulatory compliance and safety standards.

Therefore, I cannot provide a response based on the requested information regarding acceptance criteria and study details for an AI/ML device.

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