Vivid T9/Vivid T8

The Vivid T9/Vivid T8 is a general-purpose diagnostic ultrasound system specialized for cardiac imaging. It is a mobile console with LCD touchscreen, monitor, and array transducers supporting B-mode, Doppler, color, and harmonic imaging across multiple clinical applications (cardiac, vascular, abdominal, obstetric, musculoskeletal, etc.). It is intended for use by trained healthcare professionals in hospital echo labs, operating rooms, catheterization labs, and private medical offices.

The Vivid T9/Vivid T8 employs the same fundamental scientific technology and transducers as its predicate device K221147. The main differences are software features: Clarity+ (real-time noise suppression similar to Advanced SRI-HD on LOGIQ Fortis), DICOM Encapsulated PDF reports, Remote Viewing (same as Vivid S70N/S60N), and One-click QuickApps shortcuts. Hardware differences are ergonomic: Vivid T9 has height-adjustable control panel and flexible monitor arm; Vivid T8 has fixed control panel and optional flexible monitor arm.

IEC 60601-1-2:2020, IEC 60601-2-37:2015, ISO 10993-1:2018, ISO 14971:2019, IEC 62359:2017, NEMA PS 3.1–3.20 (DICOM), AAMI/ANSI ES60601-1:2005/A2:2021, and AAMI TIR69:2017/(R2020). Testing included acoustic output, biocompatibility, electromagnetic compatibility, thermal/electrical/mechanical safety, and cleaning/disinfection effectiveness.

The proposed device is substantially equivalent because it uses identical transducers and clinical indications as predicate K221147, adds only new software features that are either similar to features already cleared on other devices (Clarity+ like Advanced SRI-HD on LOGIQ Fortis; Remote Viewing like Vivid S70N/S60N) or pose no new safety/efficacy concerns (QuickApps, DICOM PDF), and adds Vascular Access—an indication already cleared on reference device Vivid S70N/S60N. No clinical studies were required; conformance to recognized safety standards and performance testing demonstrate equivalent safety and effectiveness.