Vivid iq

The Vivid iq is a compact, portable diagnostic ultrasound system designed primarily for cardiovascular imaging and shared services. It performs B-mode, Doppler, harmonic, and 3D imaging across multiple clinical applications including cardiac, abdominal, obstetric, vascular, and interventional guidance. The system includes a mobile cart with battery capability, touch-panel controls, and network connectivity for image storage and DICOM transfer.

The Vivid iq employs the same fundamental ultrasound imaging technology as its predicate device. Key additions include: Sleep mode (reduces battery consumption by 22%), Clarity+ image filtering (similar to Advanced SRI-HD on predicate systems), DICOM-encapsulated PDF reporting, remote viewing over local networks, Carto 3 digital video streaming capability, one-click QuickApps shortcuts, and compatibility with two new OEM ultrasound catheters (AcuNav Crystal and SOUNDSTAR Crystal) via an additional ICE Cord-RS connector.

AAMI/ANSI ES60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), IEC 62359 (thermal and mechanical indices), NEMA PS 3.1-3.20 (DICOM), and AAMI TIR69:2017 (RF wireless coexistence).

The proposed Vivid iq is substantially equivalent because it uses identical fundamental ultrasound technology and maintains the same indications for use as the predicate Vivid iq (K221148), with the addition of Vascular Access capability already cleared on the reference device Vivid S70N/S60N. All new software features (Sleep mode, Clarity+, DICOM PDF, remote viewing, Carto 3 integration, QuickApps) are either analogous to features already cleared on reference devices or are non-diagnostic enhancements. The new transducer compatibilities and accessories do not change clinical performance. Device testing confirms conformance to all applicable safety and performance standards.