HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

The HERA Z20/Z20e/Z20s, R20, HERA Z30, and R30 are general-purpose, mobile diagnostic ultrasound systems that acquire and display 2D, Doppler, M-mode, and 3D/4D ultrasound images for clinical diagnosis across fetal/obstetric, abdominal, cardiac, musculoskeletal, and other applications. They are intended for use by qualified healthcare professionals in hospitals, clinics, and private practices.

The proposed devices employ the same fundamental ultrasound imaging technology as the primary predicate (HERA Z20/R20/HERA Z30/R30, K241971). Key differences include: addition of ophthalmic clinical application; new AI/ML-based software features (AbdomenAssist, BladderAssist, QualityCheck, PelvicAssist); migrated and updated features from secondary predicate (NerveTrack detection, EzVolume, UterineAssist); 11 new transducers; expanded EzStructure and AutoEF applications; and software enhancements to CEUS+. All systems have identical imaging modes, measurement capabilities, and real-time acoustic output displays.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-4-2, ISO 10993-1, ISO 14971, NEMA UD 2-2004. Testing included acoustic output, biocompatibility, software function, electrical safety, electromagnetic compatibility, thermal and mechanical safety, and cleaning/disinfection effectiveness.

Substantial equivalence is established because the proposed devices have the same clinical intended use, identical imaging modes and capabilities, and employ the same fundamental ultrasound technology as the primary predicate. AI/ML features and new transducers are incremental enhancements; their safety and effectiveness are supported by non-clinical testing, algorithm validation on large datasets (40–43,000+ images), and compliance with applicable safety standards. The systems maintain equivalent measurement, imaging, and reporting functionality with no new safety concerns.