SpineUs
Contact for pricing
Regulatory Status Disclosed
Overview
SpineUs™ by Verdure Imaging is an AI-enabled 3D ultrasound system designed for spinal imaging. It is intended for use by trained chiropractors and radiologists in both clinical and hospital settings. The system provides real-time, non-invasive imaging without ionizing radiation, allowing for repeat scans and continuous monitoring.
- What it does: SpineUs™ captures volumetric ultrasound data of the spine. AI-driven segmentation models identify and reconstruct spinal anatomy in real time, generating 3D views. It is intended to assist in acquiring, viewing, and measuring ultrasound images of the spine, including spinal alignment and deformities.
- Who it is for: The tool is for trained chiropractors and radiologists. It is suitable for various care settings, including clinics and hospitals.
- How it fits a clinical or practice workflow: The system is designed for streamlined integration into existing practices. A typical workflow involves positioning a probe on the patient’s back, sweeping to capture 3D ultrasound data, AI segmentation of the anatomy, and immediate review of the 3D reconstruction. It can be used as an adjunct to conventional imaging methods.
- Notable capabilities: Key features include AI-driven segmentation validated against X-ray and CT, zero radiation dose, and an open platform architecture built on 3D Slicer. It is FDA 510(k) cleared. The system can measure spine-related anatomical components such as intervertebral angles and spine curvature.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered 3D ultrasound imaging
- Real-time spinal imaging
- Non-invasive and radiation-free
- Accurate measurement of spinal alignment and deformities
- 3D reconstruction of the spine surface
- Automated image segmentation using AI
- Patient measurement data review and management
- Exportable printable reports
- Portable and easy to use
- Integrates with Clarius Ultrasound Scanner
Use Cases
- Diagnostic imaging of the spine
- Assessing spinal alignment and deformities (e.g., scoliosis)
- Mass screening
- Monitoring spinal health
- Patient engagement and education
- Assisting interventional procedures
What Physicians Need to Know
DICOM Support & Standards
SpineUsu2122 system demonstrates compliance with NEMA PS 3.1 u2013 3.20 Digital Imaging and Communications in Medicine (DICOM) Set standards.
Reading Room Workflow Impact
Designed to streamline workflow, SpineUsu2122 offers faster, more accurate diagnostics and real-time 3D visualization of spinal alignment. It enables continuous monitoring and enhanced patient understanding by providing clear visuals to explain care plans. The system assists in acquiring, viewing, segmenting, and measuring ultrasound images of the spine, and generating reports.
AI Model Architecture (deep learning approach)
SpineUsu2122 utilizes an AI-driven approach for advanced 3D imaging, specifically for segmenting ultrasound images and generating real-time 3D reconstructions of the spinal surface. The AI algorithm is capable of identifying bone structures from 2D ultrasound data and transforming them into a 3D spinal image. This foundational technology leverages deep learning to automate 3D ultrasound imaging and enhance image interpretation.
Processing Speed (per study)
The Segmentation AI model processes a single 2D ultrasound image frame at an average inference time of 140.05 frames per second, exceeding 25 frames per second. The system processes over 22 frames per second, enabling near real-time 3D reconstruction.
FDA Clearance Pathway (510k/De Novo)
SpineUsu2122 is FDA-cleared as an AI-powered 3D ultrasound imaging device for spinal care. It received 510(k) clearance (K241029) in October 2024, classified as a Class II device. The predicate device for this clearance was the LOGIQ E10 (K231966).
Supported Modalities (CT/MRI/X-ray/US)
SpineUsu2122 is an ultrasound-based diagnostic imaging system, specifically utilizing 3D ultrasound technology in conjunction with an FDA-cleared Clarius Ultrasound Scanner C3 HD3.
Sensitivity & Specificity Data
For the evaluated Segmentation AI model's pixel-based metrics on a single 2D ultrasound image frame, the reported sensitivity is 41.80% and specificity is 99.19%. Other metrics include precision at 38.70%, Dice Coefficient at 0.4019, and balanced accuracy at 70.49%.
RSNA/ACR Validation
While there is no explicit mention of formal RSNA or ACR validation programs for SpineUsu2122, Verdure Imaging has collaborated on research comparing 3D ultrasound with CT imaging and advancing AI development, with support from experts at institutions like Jefferson University.
Physician Tip
SpineUsu2122 offers a radiation-free, non-invasive alternative for spinal imaging, particularly beneficial for frequent monitoring and pediatric patients. Leverage its real-time 3D visualization and AI-driven measurements for enhanced patient education and improved communication of care plans. Consider its potential for guiding interventional procedures by providing high-resolution, real-time ultrasound imaging. Remember that SpineUsu2122 is intended as an adjunct to conventional imaging methods, and clinical judgment remains paramount for patient management decisions. Its portability and ease of use can facilitate integration into various clinical settings.
SpineUsu2122 operates as a software-based system installed on a consumer PC, processing data from a Clarius Ultrasound Scanner and an optical tracking system. Its DICOM compliance ensures compatibility with existing healthcare IT infrastructure for patient data and image archival. The system's design emphasizes seamless integration into existing practice workflows.
Details
| Category | Radiology & Imaging AI |
| Pricing | Contact for pricing — Affordable technology with established reimbursable spinal imaging codes. |
| Deployment | On-premise (requires specific hardware including a consumer PC, Clarius Ultrasound Scanner, and tracking system) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The SpineUs™ System (K241029) received a Substantially Equivalent (SE) decision from the FDA on October 7, 2024. It is indicated for diagnostic ultrasound imaging in musculoskeletal (conventional, superficial) applications, intended for use by trained chiropractors and radiologists. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
Ratings & Reviews
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Press & Coverage
vertexaisearch.cloud.google.com (redirect from FDA)
SpineUsu2122 System | FDA Radiology AI Device - X-ray Interpreter
The SpineUsu2122 System by Verdure Imaging is a diagnostic ultrasound platform intended to assist trained chiropractors and radiologists in acquiring, viewing, segmenting, and measuring ultrasound images of the spine in clinical settings. It is designed to be an adjunct to conventional imaging methods, allowing for measurements of spine-related anatomical components like intervertebral angles and spine curvature.
2024-10
accessdata.fda.gov
510(k) Premarket Notification - SpineUsu2122 System
This FDA 510(k) summary details the SpineUsu2122 System, a software-based, tracked ultrasound imaging system intended for diagnostic musculoskeletal imaging of the spine. It outlines the device's description, intended use, and substantial equivalence to a predicate device, the GE Medical Systems Ultrasound LOGIQ E10.
2024-10
Verdure Imaging
About Us - Verdure Imaging
Verdure Imaging aims to revolutionize healthcare with AI-enabled imaging solutions, introducing SpineUsu2122 as the world's first FDA 510(k) cleared 3D spine ultrasound. The technology combines 3D ultrasound, AI-enabled segmentation, and clinical validation to provide safer, more accessible, and useful spinal imaging.
unknown
Verdure Imaging
Revolutionizing Spinal Care with 3D Ultrasound Technology
This page introduces SpineUsu2122 as the world's first AI-enabled 3D ultrasound for spinal imaging, highlighting its key features such as FDA 510(k) clearance, AI-driven segmentation, zero radiation dose, and open platform architecture. It also mentions collaborations with leading institutions like Thomas Jefferson University Hospital.
2026-02
FDA
K241029 - 510(k) Premarket Notification
This FDA document is a 510(k) Premarket Notification for the SpineUsu2122 System, submitted by Verdure Imaging. It lists the applicant, contact person, and regulatory information, including the classification product code IYO.
2026-07
Buyer shortlist
Ultrasound workflow radiology AI tools | Buyer shortlist
This article lists various ultrasound workflow radiology AI tools, including the SpineUsu2122 System by Verdure Imaging, which is described as an image analysis/processing tool for the spine using ultrasound, with an FDA-cleared K241430.
2024-10
Verdure Imaging
Research & Validation - Verdure Imaging
Verdure Imaging's research and validation page highlights peer-reviewed studies supporting SpineUsu2122, including an article in the European Spine Journal (2025) on 3D ultrasound measuring spinal alignment as accurately as X-ray, and a 2020 IEEE Transactions on Medical Imaging article on automated 3D ultrasound imaging of the spine using deep learning.
2025
FDA.report
System, Imaging, Pulsed Echo, Ultrasonic IYO - FDA.report
This entry from FDA.report lists the SpineUsu2122 System by Verdure Imaging with its 510(k) clearance date of October 7, 2024, under the product code IYO for Ultrasonic Pulsed Echo Imaging Systems.
2024-10
Videos
Product demos, reviews, and walkthroughs for SpineUs.
SpineUsu2122 | The Worldu2019s First AI-Powered 3D Spine Ultrasound
SpineUs
Frequently Asked Questions
SpineUsu2122 is designed as an AI-enabled 3D ultrasound imaging system that integrates seamlessly into your practice, offering real-time spinal imaging. It can be used for diagnostic imaging, assisting in measuring spine-related anatomical components and visualizing spinal deformities.
While specific details on data encryption and storage protocols would require direct vendor inquiry, as an FDA-cleared medical device, SpineUsu2122 must adhere to stringent regulatory standards for patient data security. It is designed for use in professional healthcare environments, implying compliance with relevant privacy regulations like HIPAA.
Yes, SpineUsu2122 is the first FDA-cleared, AI-powered 3D ultrasound imaging device specifically designed for spinal care. This clearance indicates it has met the safety and effectiveness standards required for medical devices in the United States.
SpineUsu2122 distinguishes itself as an ultrasound-based system, offering a non-invasive, radiation-free alternative to traditional imaging like X-rays for spinal assessment. Other AI tools often focus on interpreting CT or MRI scans for various spinal pathologies or aiding in surgical planning.
SpineUsu2122 is presented as a cost-effective solution with established reimbursable spinal imaging codes, aiming to enhance practice efficiency. Specific pricing models (e.g., subscription, one-time purchase) and detailed implementation costs would need to be obtained directly from Verdure Imaging.
While AI in spine care offers enhanced precision, its reliability is tied to the quality of training data, and external validation can be limited. SpineUsu2122 is intended to be used as an adjunct to conventional imaging, and clinical judgment and experience are required, meaning patient management decisions should not be made solely based on its results.
The device is designed to be easy to use by healthcare professionals with varying levels of experience. While specific training programs are not detailed, the company emphasizes empowering medical professionals, suggesting that support and training would be part of the adoption process for this innovative technology.
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| Last Verified: 2026-04-21 | First Added: 2026-04-21