ScanDiags Ortho L-Spine MR-Q
Overview
ScanDiags Ortho L-Spine MR-Q is an AI-powered Software as a Medical Device (SaMD) designed for the visualization and quantification of lumbar spine anatomical structures from standard DICOM MRI images. The software employs deep learning, image analysis, and regression-based machine learning methods to perform semi-automatic segmentation of structures such as vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. It provides distance and area measurement outputs, which are user-modifiable. The tool assists radiologists by generating PDF reports that include images and measurements, which are reviewed and approved by the radiologist before being sent to the clinician’s PACS system. ScanDiags Ortho L-Spine MR-Q is an adjunct tool, not intended to replace a radiologist’s review or clinical judgment, and does not detect, diagnose, or identify abnormalities. It is compatible with all MRI hardware platforms and integrates seamlessly into existing radiology operations, uploading previously generated DICOM data files for analysis.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Combines deep learning, image analysis, and regression-based machine learning methods
- Visualization and quantification of lumbar spine anatomical structures
- Semi-automatic segmentation of vertebral bodies, intervertebral discs, neuroforamina, thecal sacs
- Distance and area measurement outputs
- User-modifiable segmentations and distance measurements
- Generates PDF reports with images and measurements
- Integrates with PACS systems for report storage
- Includes ScanDiags DICOM Viewer for review and corrections
- Manufacturer-, PACS-, and parameter-independent
- Performs at or above human precision
Use Cases
- Augmented diagnosis from musculoskeletal MRI
- Standardized diagnostic reports in an automated process
- Unburdening clinicians and increasing radiology workflow capacity
- Assisting radiologists in reviewing and interpreting lumbar spine MRI studies
- Providing quantitative spine measurements
What Physicians Need to Know
Utilize ScanDiags Ortho L-Spine MR-Q as a quantitative aid for lumbar spine MRI analysis, focusing on its ability to provide objective measurements and segmentations of vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. Remember that the tool is supplementary; always exercise clinical judgment and perform a thorough review of the original MRI study. Leverage the user-modifiable segmentations to refine results and ensure accuracy before generating the final PDF report. The automated measurements can significantly streamline report generation, allowing more focus on complex diagnostic interpretations. Be aware of the specified input criteria, such as patient age and exclusion of contrast studies or specific patient conditions, to ensure appropriate use of the software.
ScanDiags Ortho L-Spine MR-Q integrates into the existing radiology workflow by accepting pre-acquired DICOM MRI images. The primary output for integration with hospital systems is a PDF report, which is sent to the clinician's PACS system and stored with the patient's MRI study. This method avoids direct real-time interfacing with MR equipment or direct DICOM output back to PACS, simplifying deployment but requiring a workflow that accommodates PDF report ingestion into PACS. Ensure your PACS can effectively store and display these PDF reports alongside the original imaging studies for comprehensive patient records.
Details
| Category | Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Software as a Medical Device (SaMD) with PACS integration |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated ScanDiags Ortho L-Spine MR-Q software received 510(k) clearance from the FDA on February 21, 2025, as a Class II medical device (Product Code QIH) for visualization and quantification of lumbar spine anatomical structures from standard MRI images. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
What the Web Says
ScanDiags Ortho L-Spine MR-Q is an AI-powered software tool designed to assist physicians in analyzing lumbar spine MRI images. It provides quantitative measurements of anatomical structures like vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs using deep learning algorithms for semi-automatic segmentation. The software aims to save time by automating manual measurement tasks and generating PDF reports, but it is intended as an adjunct tool and not a replacement for a radiologist's expert interpretation or clinical judgment.
Overall: MixedStrengths
- Automates tedious manual segmentation and measurement tasks, saving time for clinicians.
- Utilizes deep convolutional neural networks (DCNN) and machine learning for semi-automatic segmentation and measurements, offering high accuracy.
- Provides quantitative spine measurements from previously acquired DICOM lumbar spine MR images.
- Allows users to review and modify segmentations and measurements before generating PDF reports.
- Independent of MRI acquisition equipment and vendor.
- Validated in studies showing high intraclass correlation coefficients (ICCs) for measurements and Dice similarity coefficients for segmentation accuracy.
Limitations
- Not intended to replace a radiologist's review, clinical judgment, or to detect/diagnose abnormalities.
- Radiologists must not use the generated output as a primary interpretation.
- Only for use with DICOM lumbar spine MR images of patients aged 22 and above; not for pregnant patients, those with contrast media, post-operational complications, or infections.
- No direct reviews or opinions from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for this specific product.
- General concerns exist regarding the potential for misdiagnosis in lumbar spine MRIs, even with expert interpretation, highlighting the need for careful review of AI-generated results.
Based on reviews from: FDA Radiology AI Device - X-ray Interpreter, ScanDiags | Radiology AI Companies - X-ray Interpreter, accessdata.fda.gov, Microsoft Marketplace, Reddit (r/ChronicPain), Reddit (r/backpain), Reddit (r/orthopaedics), G2, MDView, Capterra, Emeralgo
Last updated: 2026-07-18
Ratings & Reviews
Rate ScanDiags Ortho L-Spine MR-Q
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for ScanDiags Ortho L-Spine MR-Q.
