V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

The V8/cV8, V7/cV7, and V6/cV6 are general-purpose, mobile diagnostic ultrasound systems that acquire and display ultrasound images in multiple modes (2D, Color Doppler, Power Doppler, M mode, PW/CW Doppler, TDI, TDW, ElastoScan, 3D/4D) and analyze body fluids. They are intended for clinical diagnosis across diverse applications including fetal/obstetric, abdominal, cardiac, vascular, and musculoskeletal imaging, used by trained healthcare professionals in hospitals, clinics, and private practices.

The proposed devices employ the same fundamental ultrasound imaging technology as their primary predicate (V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6, K240631), with identical imaging modes and measurement capabilities. Key updates include: addition of 'EzNerveMeasure' (a cleared AI-based sub-function of NerveTrack for nerve segmentation), 'RFA Viewer' for real-time ablation monitoring, expanded 'Strain+' measurement items (left atrium and right ventricle), expanded 'AutoEF' with Global Longitudinal Strain measurement, and inclusion of a new transducer (BCL2-14) with validated biocompatibility and image performance.

IEC 60601-1 (general medical electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic diagnostic equipment), IEC 60601-4-2 (electromagnetic immunity), ISO 10993-1 (biocompatibility evaluation), ISO 14971 (risk management), and NEMA UD 2-2004 (acoustic output measurement). All software verification and validation testing met acceptance criteria.

Substantial equivalence is established because the proposed device and primary predicate share the same intended use (diagnostic ultrasound imaging across multiple clinical applications), identical imaging modes and operational capabilities, and the same fundamental technology platform. All additions (EzNerveMeasure, RFA Viewer, expanded strain/EF measurements, new transducer) are either previously-cleared functions with expanded features or new components subjected to appropriate biocompatibility and performance testing. Both devices comply with the same electrical, physical, and acoustic safety standards, have similar measurement and reporting functionality, and operate with acoustic power below FDA limits.