Search Results

The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative

The Acclarix AX8 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as HPRF. Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging, Multi-Beam-Forming, Speckle Resistance Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle Visualization, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images, following Track 3 for all applications in the 510(k) submission.

The provided text is a 510(k) summary for the Edan Acclarix Diagnostic Ultrasound System. It details the device's indications for use and compares it to predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

The document states:

• "Clinical test: Clinical testing is not required."
• "Non-clinical test: The Acclarix AX8 Ultrasound Imaging System complies with: (1) IEC 60601-1 Electrical Safety, (2) IEC 60601-1-2 Electromagnetic Compatibility, (3) Acoustic output testing as per the guideline 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008. The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1, ISO 10993-5 and ISO 10993-10. The tests were selected to show substantial equivalence between the subject device and the predicate."

This indicates that the device's equivalence to existing devices was established through adherence to recognized electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility standards, rather than through specific performance metrics outlined in a clinical or detailed non-clinical study for acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through compliance with general safety and performance standards, not through detailed acceptance criteria with reported device performance figures from a specific study.

Ask a specific question about this device