Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
Edan Instruments Inc.The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.
Intended Use
The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems are intended for use by qualified physicians or allied health professionals for ultrasound evaluations in hospitals and clinics across multiple clinical specialties including abdominal, cardiac, musculoskeletal, vascular, and pediatric imaging.
Technology
These are software-controlled diagnostic ultrasound systems comprising a main unit and associated transducers, operating in multiple modes such as B mode, M mode, Doppler mode, Harmonic Imaging, Elastography, and Contrast imaging. They include new transducers and advanced features like Stress Echo and Auto LVOT-D to support diverse ultrasound imaging needs.
Performance
Performance testing included electrical safety, electromagnetic compatibility, bench testing per IEC standards, and software verification and validation testing, demonstrating that the devices meet relevant guidance and consensus standards and are as safe and effective as the predicate devices. Clinical testing was not applicable.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/24/2025
27 days - 2
FDA Approval
2/20/2025
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