Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8)

The MX7 series diagnostic ultrasound systems are general-purpose, mobile ultrasound devices designed for acquiring and displaying ultrasound images in multiple modes (B, M, Doppler, color flow, harmonic imaging, 3D/4D, elastography, and contrast imaging). They are intended for use by qualified healthcare professionals in hospitals and clinics for imaging a wide range of anatomical applications including cardiac, abdominal, obstetric, pediatric, vascular, and musculoskeletal examinations across adult, pediatric, and neonatal patients.

The subject devices use the same acoustic power levels below FDA limits, the same electrical and physical safety design standards, and equivalent transducers and needle-guided brackets as predicate devices. Key features include automated measurement functions (Auto VM, Smart FV), workflow templates (HD Access works), and a probe adapter (PCM-CWS01) for interface conversion. Additional features such as VA Grid, Smart Face, TTQA-RV, X-link, Air Capsule, and iVocal Plus represent enhancements or combinations of previously cleared functions from multiple predicate devices.

NEMA UD 2-2004 (acoustic output), ANSI AAMI ES60601-1:2005 (electrical safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 60601-2-37 (ultrasonic equipment safety), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), IEC 62304 (software lifecycle), and IEC 62366-1 (usability engineering).

The device is substantially equivalent because it has the same intended uses as predicate MX7 (K241432) except for laparoscopic use, which is covered by predicate TEX20 (K241201). All new features and functions are either direct equivalents to predicate devices or enhancements of already-cleared functions from multiple predicates (TEX20, Resona I8W, TE Air, QLAB). The subject devices maintain the same acoustic safety profile and comply with identical electrical and physical safety standards as the predicates. No new clinical risks are introduced, and non-clinical testing demonstrates safety and effectiveness equivalent to predicates.