FDA.report

VERDURE IMAGING INC

Matched from indexed company URL: Verdure Imaging

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30353734463035373446VERDURE IMAGING INC1N2026-01-014560 N Pershing Ave Ste B Stockton CA US 95207

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3357741429989435K241029SpineUs™ SystemIYO2024-10-07

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYO12024-10-07

PMN

GUDID

SpineUs System - 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.

VERDURE IMAGING, INC.

2025-01-20