Search Results

The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

The ACUSON Juniper Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

The 13L4 needle guide kit is newly introduced on this submission.

This document, K201130, is a 510(k) premarket notification for the ACUSON Juniper Diagnostic Ultrasound System. It asserts substantial equivalence to previously cleared devices.

Based on the provided text, there is no acceptance criteria or study data for AI/ML-driven features because this 510(k) is for a diagnostic ultrasound system and does not describe an AI/ML-driven device. The relevant sections of a typical AI/ML submission (e.g., acceptance criteria, test set details, ground truth establishment, or clinical studies demonstrating AI performance) are therefore absent.

The document discusses the system's intended use for various diagnostic ultrasound applications and its technological characteristics compared to predicate devices. It states that "clinical data is not required to support substantial equivalence" because the device uses the "same technology and principles as existing devices." This statement further confirms that no new clinical performance studies, such as those that would be conducted for AI/ML device validation, were performed or required for this submission.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets these criteria for an AI/ML product based on this K201130 document.

Ask a specific question about this device