V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

The V8/cV8, V7/cV7, V6/cV6, V5/cV5, and V4/cV4 are general-purpose diagnostic ultrasound systems designed to acquire and display ultrasound images in multiple modes (2D, Doppler, M-mode, 3D/4D, etc.) for clinical diagnosis across fetal, cardiac, abdominal, vascular, and other applications. They are intended for use by trained healthcare professionals in hospitals, clinics, and private practices.

The proposed devices employ the same fundamental ultrasound imaging technology as the predicate V8/cV8, V7/cV7, V6/cV6 (K243702). Key updates include: revised AI models for BiometryAssist, ViewAssist, and HeartAssist features; new educational features (EzAssist, EzTrainer) not for diagnostic use; a new transducer (LM2-18D); expanded clinical applications including Transesophageal Cardiac and Dermatology; and updated cardiac analysis functions (Strain+, AutoEF) with expanded measurement parameters.

IEC 60601-1:2005 (medical device safety), IEC 60601-1-2:2014 (EMC), IEC 60601-2-37 (ultrasound equipment), ISO 10993-1:2018 (biocompatibility), ISO 14971:2019 (risk management), NEMA UD 2-2004 (acoustic output measurement). All software verification and validation tests met acceptance criteria.

The proposed devices share the same intended use, clinical applications, modes of operation, and measurement/reporting capabilities as the predicate device. The fundamental ultrasound technology is identical. New features (BiometryAssist, ViewAssist, HeartAssist AI models) are updates to cleared functions with validated performance; educational features (EzAssist, EzTrainer) have no diagnostic purpose. The addition of one new transducer and expanded cardiac measurement parameters represent incremental, functionally equivalent enhancements. All devices comply with the same applicable safety and performance standards and demonstrate acoustic power levels below FDA limits, supporting equivalent safety and efficacy.