Search Results

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

The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide. 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.

This document is a 510(k) Premarket Notification for the GE LOGIQ 9 Diagnostic Ultrasound System with IQ Filter. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to a new AI/filter feature.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No new AI/filter feature with performance claims: The key modification mentioned is the "IQ Filter" and "image enhancement". However, the document explicitly states in "Section b): 2. Clinical Tests: None required." This indicates that no new clinical performance claims were being made that would necessitate a study with acceptance criteria.
• Focus on substantial equivalence: The core of this 510(k) is demonstrating "substantial equivalence" to a predicate device (the current GE LOGIQ 9) based on having the "same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes." This means the general safety and effectiveness of ultrasound is already established, and the IQ filter is presented as an enhancement within those established parameters, not a new functional capability requiring its own detailed performance study against specific criteria.
• Safety and engineering tests: The non-clinical tests focused on acoustic output, biocompatibility, cleaning, and thermal/electrical/mechanical safety—standard requirements for medical devices, not performance criteria for a specific new image processing algorithm.

Therefore, since the document states "Clinical Tests: None required," and the submission is focused on substantial equivalence based on existing device characteristics, there is no detailed information available in this text regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for the "IQ Filter" or "image enhancement" feature.

The document concludes by stating: "Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 9 BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." This reinforces that the submission did not hinge on demonstrating new, quantified performance metrics for the added feature.

Ask a specific question about this device