SpineUs System

Primary DI

G618000010

Brand

SpineUs System

Company

VERDURE IMAGING, INC.

Model

000010

Device description

The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.

Published

2025-01-20

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Rx

false

OTC

false

Sterile

false

Single use

false