FractureDetect (FX)

by Imagen Technologies  · Based in United States → — AI-Enabled Imaging Solutions For Superior Quality and Outcomes.
Emergency Medicine Orthopedics Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device developed by Imagen Technologies. It leverages robust scientific principles and industry-standard deep learning algorithms for computer vision to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX analyzes adult radiographs and provides relevant annotations, creating a DICOM overlay that indicates the presence or absence of fractures. This overlay can be toggled on or off within the clinician’s PACS viewer, allowing for uninhibited concurrent review of the original radiograph. The device is specifically indicated for adults only and supports various industry-standard radiographic views and study types across the musculoskeletal system, including areas like the ankle, clavicle, and other upper and lower extremities, and pelvis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Computer-assisted detection and diagnosis (CAD) for fractures
  • Utilizes deep learning algorithms for image analysis
  • Analyzes musculoskeletal radiographs in adults
  • Provides relevant annotations and DICOM overlays
  • Indicated for adults only
  • Supports multiple radiographic views and study types (e.g., ankle, clavicle, pelvis, upper/lower extremities)
  • Improves clinician diagnostic accuracy and confidence
  • Reduces missed fractures in clinical settings
  • Seamlessly integrates into existing PACS workflows

Use Cases

  • Assisting clinicians in detecting fractures during radiograph review at the point of care
  • Improving diagnostic accuracy for various clinician types, including radiologists, emergency medicine physicians, and primary care physicians
  • Reducing diagnostic errors and misinterpretations in emergency departments
  • Enhancing clinician experience and productivity by streamlining diagnostic workflows
  • Enabling earlier detection and intervention for musculoskeletal fractures
  • Supporting in-office imaging solutions within primary care and other practices

What Physicians Need to Know

DICOM Support & Standards
FractureDetect (FX) processes DICOM images from standard imaging devices or DICOM nodes. It creates a DICOM overlay with annotations indicating the presence or absence of fractures.
PACS Integration Method
The FX overlay can be toggled on or off by clinicians within their PACS viewer, allowing for uninhibited concurrent review of the original radiograph.
Reading Room Workflow Impact
AI assistance in fracture detection has been associated with reductions in image interpretation time and improvements in inter-reader agreement. FractureDetect (FX) is designed to assist clinicians in detecting fractures during the review of musculoskeletal radiographs.
AI Model Architecture (deep learning approach)
FractureDetect (FX) was developed using industry-standard deep learning algorithms for computer vision. It utilizes a proprietary Convolutional Neural Network (CNN) for classification, outputting a probability score.
FDA Clearance Pathway (510k/De Novo)
FractureDetect (FX) received 510(k) clearance (K193417) on July 30, 2020. Its predicate device, OsteoDetect, received De Novo clearance.
Supported Modalities (CT/MRI/X-ray/US)
FractureDetect (FX) is indicated for use with radiographs (X-ray) of the musculoskeletal system. It supports various radiographic views for ankle, clavicle, elbow, femur, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, and wrist.
Sensitivity & Specificity Data
In a standalone performance assessment on 11,970 radiographs, FractureDetect (FX) achieved a sensitivity of 95.1% and specificity of 89.3%, with an AUC of 0.982. When used by emergency medicine physicians, the algorithm improved sensitivity from 74.7% to 80.3% and specificity from 88.9% to 91.4%.
RSNA/ACR Validation
Definitions of anatomic area of interest and radiographic views for FractureDetect (FX) are consistent with American College of Radiology (ACR) standards and guidelines. The ACR Data Science Institute (DSI) lists OsteoDetect as the first fracture-related algorithm cleared by the FDA.
Physician Tip

FractureDetect (FX) is intended as an assistive tool for adult radiographs, not a replacement for clinical judgment. The AI overlay can be toggled on/off in PACS for flexible review. While it covers a broad range of musculoskeletal views, it's crucial to remember it's not cleared for pediatric fractures. The tool has demonstrated improved diagnostic performance for clinicians, particularly in sensitivity.

FractureDetect (FX) is designed to integrate into existing radiology workflows by processing DICOM images from standard imaging devices or DICOM nodes and providing a DICOM overlay within the PACS viewer.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Emergency Medicine, Orthopedics, Radiology

What the Web Says

FractureDetect (FX) by Imagen Technologies is an AI-powered software designed to assist clinicians in detecting fractures in adult musculoskeletal radiographs. It analyzes X-ray images and provides annotations to highlight potential fractures, aiming to improve diagnostic accuracy and reduce missed fractures. The software has received FDA clearance and has demonstrated improved sensitivity and specificity for clinicians when used as an aid.

Overall: Positive

Strengths

  • Improves diagnostic accuracy for clinicians, especially those with limited musculoskeletal imaging training.
  • Increases sensitivity and specificity in fracture detection.
  • FDA-cleared for use in adults across various anatomical regions.
  • Can be integrated into existing PACS viewers with a togglable overlay.
  • Potential to reduce missed fractures and expedite diagnosis.

Limitations

  • Some Reddit discussions express skepticism about AI replacing radiologists and concerns about over-reliance on AI.
  • Concerns raised on Reddit about potential underpayment of radiologists by companies leveraging AI, and the quality of reads in such models.
  • One Reddit comment suggests that AI excels with apparent fractures but may fail with cases requiring complex reasoning.
  • Some AI fracture detection tools, in general, may overdiagnose or have technical problems that delay results.
  • The information regarding development, performance evidence, and target population for some AI solutions is not always clear.

Based on reviews from: National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), American Journal of Roentgenology (AJR), ResearchGate, Health AI DB, Innolitics, Braid Health, AuntMinnie.com, BoneZonePub.com, Reddit

Last updated: 2026-10-30

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Press & Coverage

fda.gov
FractureDetect (FX) FDA 510(k) Premarket Notification
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device developed by Imagen Technologies to assist clinicians in detecting fractures in adult radiographs of the musculoskeletal system. It analyzes radiographs and provides annotations to aid in fracture detection at the point of care. The device was cleared by the FDA on July 30, 2020.
2020-07
mdpi.com
Artificial intelligence in musculoskeletal radiology: current applications and future directions
This peer-reviewed article discusses FractureDetect (FX) as an AI-based algorithm that localizes bone fractures on radiographs across various anatomical locations, including the shoulder, humerus, elbow, forearm, femur, knee, tibia, fibula, ankle, pelvis, hip, and clavicle. The algorithm achieved an AUC of 0.98, a sensitivity of 95%, and a specificity of 89% on a testing dataset of 11,970 radiographs.
2024-03
oup.com
Artificial intelligence in orthopaedics: a systematic review of current applications
This article mentions FractureDetect (FX) by Imagen Technologies as a radiography-based AI tool for detecting acute fractures in the upper and lower extremities. It notes that the product specifically includes ankle, clavicle, elbow, femur, forearm, hip, humerus, and knee views.
2023-12
ajronline.org
Artificial Intelligence in Clinical Radiology: Current Applications and Future Perspectives
FractureDetect (Imagen Technologies) is highlighted for its ability to detect fractures across a range of radiographs of the upper and lower extremities, pelvis, and clavicle, incorporating multiple projections into its predictions. The product is intended to assist clinicians in detecting fractures in adult radiographs.
2026-03
nih.gov
Artificial Intelligence in Trauma Imaging: A Review of Current Applications and Future Directions
This review article lists Imagen FractureDetect FX as a notable example of general fracture detection CAD capable of detecting pelvic, spinal, and proximal femoral fractures on radiographs, including trauma series pelvic radiographs. It also notes that these tools often use heatmaps or box detections for explainability.
2025-03
orthogonal.io
FDA-Cleared SaMD: The Ultimate Running List
FractureDetect (FX) by Imagen Technologies, Inc. is included in a comprehensive list of Software as a Medical Devices (SaMD) cleared by the FDA. The article specifies that FractureDetect (FX) received its FDA clearance on July 30, 2020, for use in Radiology.
2024-10
spandidos-publications.com
AI in Healthcare: A Comprehensive Review of FDA-Approved AI-Based Medical Devices
This review article lists FractureDetect (FX) by Imagen Technologies as an FDA-approved AI-based medical device for diagnosis in Radiology, with its approval occurring in 2020. It is part of a broader discussion on the increasing number of AI-based applications approved by the FDA in recent years.
2021-09
nih.gov
Commercial Artificial Intelligence Solutions for Fracture Detection: A Systematic Review
This systematic review identifies FractureDetect (FX) as a commercially available AI solution for fracture detection. It references the FDA documentation for FractureDetect (FX) (Ref: K193417) from 2020.
2024-02

Videos

Product demos, reviews, and walkthroughs for FractureDetect (FX).

View all on YouTube

Frequently Asked Questions

FractureDetect (FX) is designed to integrate with existing PACS systems, providing AI-powered fracture detection and automated reporting. The software creates a DICOM overlay with annotations indicating the presence or absence of fractures, which can be toggled on or off within the PACS viewer for concurrent review of the original radiograph.
FractureDetect (FX) by Imagen Technologies is FDA-cleared as a computer-assisted detection and diagnosis (CAD) software device. It is intended to assist clinicians in detecting fractures during the review of musculoskeletal radiographs in adults.
FractureDetect (FX) is indicated for use in adults only and detects fractures across a range of radiographs including upper and lower extremities, pelvis, and clavicle. It is important to remember that AI tools like FractureDetect (FX) are adjuncts and not meant to replace a clinician's review or clinical judgment.
Several other AI-powered fracture detection tools are available, including Gleamer BoneView and AZmed Rayvolve. These tools offer varying anatomical coverage, performance metrics, and regulatory clearances, with some also cleared for pediatric use.
Specific pricing for FractureDetect (FX) is not publicly available. However, pricing models for radiology AI platforms generally range from per-study costs to annual software licenses, often with additional implementation, training, and support fees.
In standalone performance assessments, FractureDetect (FX) has demonstrated high accuracy with an AUC of 0.982, sensitivity of 95.1%, and specificity of 89.3% on a test set of 11,970 radiographs. Studies have shown that AI assistance, including tools like FractureDetect (FX), can improve diagnostic performance and efficiency for physicians.
No, FractureDetect (FX) is indicated for use in adults only. Physicians should be aware of this limitation when considering its application in clinical practice.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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