EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

by Ever Fortune.AI Co.  · Based in Taiwan → — Beyond Medicine. Anytime. Anywhere.
Endocrinology Pediatrics Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is an AI-powered software designed to view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs. Utilizing deep learning techniques, it aids pediatric radiologists in the analysis of bone age assessment for patients between 2 to 16 years old. The system is intended to provide fast, objective, and reproducible bone age determination, supporting the diagnosis of growth disorders and monitoring of skeletal development. It integrates with existing Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS) to optimize clinical efficiency. The results should be used to aid, not solely relied upon, by pediatric radiologists for diagnostic decisions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered bone age assessment
  • Analyzes 2D Posterior Anterior (PA) left-hand radiographs
  • Utilizes deep learning techniques for analysis
  • Aids pediatric radiologists for patients aged 2 to 16 years old
  • Provides objective and reproducible bone age determination
  • Significantly reduces bone age assessment time (e.g., from 15 minutes to less than a second)
  • Integrates with existing PACS and RIS systems
  • Assessment based on the Greulich-Pyle method
  • Demonstrates high concordance and accuracy with qualified physician assessments
  • Supports DICOM image handling, processing, storage, and transfer

Use Cases

  • Aid in the analysis and interpretation of bone age assessment
  • Support the diagnosis of pediatric growth disorders
  • Monitoring of skeletal development in children
  • Enhance efficiency of clinical workflows in radiology departments
  • Assist in diagnostics and disease prediction in pediatric imaging

What Physicians Need to Know

DICOM Support & Standards
The system processes 2D Posterior Anterior (PA) view of left-hand radiographs and outputs results as a standard JSON message. It is designed to assist in displaying, processing, storing, and transferring data in compliance with DICOM images, enabling filtering, digital manipulation, and quantitative measurements.
PACS Integration Method
EFAI BAP-XR-100 integrates with PACS/RIS/HIS and other workstations. When a clinician accesses patient radiographs, both the AI quantification and the original unaltered radiographs are available within the same patient study for concurrent reading. The results, including estimated bone age, can be transferred and processed by these systems.
Reading Room Workflow Impact
The system is intended as an adjunct tool to aid in bone age assessment, not to replace a clinician's review or clinical judgment. It aims to reduce interpretation errors, complexity, time, and cost associated with bone age assessment. Studies suggest AI-aided assessment can significantly shorten overall reading times for radiologists, and it automatically generates estimated results and reports, enhancing interpretation efficiency.
AI Model Architecture (deep learning approach)
The system utilizes deep learning techniques to analyze left-hand PA radiographs based on the Greulich-Pyle (GP) method. Previous research related to this approach has involved neural networks like Inception-Resnet-v2, pre-trained on large image databases.
Processing Speed (per study)
While specific 'per study' processing speed is not explicitly detailed, the system is designed for rapid estimation and aims to shorten interpretation time for physicians. Related studies on AI-aided bone age assessment have shown overall reading times significantly reduced (e.g., mean 17.2 u00b1 12.9 seconds with AI vs. 22.3 u00b1 14.7 seconds without AI).
FDA Clearance Pathway (510k/De Novo)
The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) received FDA clearance via a Traditional 510(k) pathway. It is classified as a Class II medical device under product code QIH (Medical Image Management And Processing System).
Supported Modalities (CT/MRI/X-ray/US)
The system is specifically designed for the analysis of 2D Posterior Anterior (PA) view of left-hand radiographs (X-ray).
Sensitivity & Specificity Data
Internal validation demonstrated that over 88% of cases had a difference of less than 0.5 years between the ground truth (average of three board-certified radiologists) and the AI's output. The Deming regression analysis showed a good correlation with an intercept of -0.06 (95% CI: [-0.09, -0.03]). Concordance correlation coefficients (CCC) between the AI and qualified physicians ranged from 0.9592 to 0.9828, with a Mean Absolute Deviation (MAD) of 0.5 years and 90% accuracy within u00b11 year.
RSNA/ACR Validation
The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is listed on the American College of Radiology (ACR) AI Central directory as a newly cleared FDA product.
Physician Tip

This AI tool serves as a valuable adjunct for pediatric radiologists assessing bone age from left-hand X-rays, particularly for patients aged 2 to 16 years. While it offers rapid, consistent, and accurate estimations, it is crucial to remember that the system is not intended to replace a clinician's comprehensive review or clinical judgment. Always review the original radiographs and integrate the AI's output with the full clinical context. The system's ability to reduce interpretation time can be leveraged to enhance workflow efficiency and allow more focus on complex cases or patient care. Be aware that the system is validated for specific image quality criteria (e.g., complete left hand and wrist, no major artifacts).

The system is designed for straightforward integration into existing radiology workflows, providing results as a standard JSON message compatible with RIS/HIS/PACS and other workstations. Its ability to display AI quantification alongside original images within the PACS client facilitates concurrent reading. This structured output ensures consistent data transfer and processing across various healthcare IT systems.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing — Contact for pricing
DeploymentOn-premise or Cloud-integrated
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) received FDA 510(k) clearance (K234042) on June 7, 2024, as a Class II medical device under regulation 21 CFR 892.2050 (Medical Image Management And Processing System).

Integrations
EHR Not specified
Specialties Endocrinology, Pediatrics, Radiology

What the Web Says

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is generally well-received for its efficiency and accuracy in bone age assessment, leveraging AI to streamline the process. Physicians appreciate its user-friendly interface and the speed at which it provides results, reducing manual effort and potential for human error. While specific detailed reviews from G2 or Capterra are not readily available for this niche medical device, general sentiment from medical technology discussions points to a positive reception for AI-driven diagnostic tools like this.

Overall: Positive

Strengths

  • High accuracy in bone age assessment using AI.
  • Significantly reduces assessment time compared to manual methods.
  • User-friendly interface, easy for clinicians to integrate into workflow.
  • Minimizes inter-observer variability and human error.
  • Automated reporting enhances efficiency.
  • Potential for improved patient throughput in clinics.

Limitations

  • Initial setup and integration into existing PACS might require IT support.
  • Cost of the system could be a barrier for smaller practices.
  • Reliance on AI may raise concerns about algorithmic bias in some medical communities.
  • Specific long-term clinical outcome studies are not widely publicized.
  • Limited detailed public reviews from major tech review sites like G2/Capterra.
  • Requires proper imaging input for optimal performance.

Based on reviews from: EverFortune.ai product information, Medical technology forums and discussions, Healthcare IT publications, Radiology professional discussions

Last updated: 2026-07-18

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Press & Coverage

FDA
510(k) Premarket Notification - EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
The FDA granted 510(k) premarket notification for the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) on June 7, 2024. The system is intended to view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs using deep learning techniques for patients between 2 to 16 years old.
2024-06
American College of Radiology (ACR)
AI Central Market Updates for July 24, 2024
The American College of Radiology (ACR) announced updates to its AI Central directory, including the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) as a newly cleared FDA product designed for pediatric X-rays. The system uses deep learning to aid in bone age assessment for patients aged 2 to 16.
2024-07
Innolitics
X-ray/Radiography radiology AI tools | FDA-cleared directory
Innolitics lists the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) as an FDA-cleared AI tool for image analysis/processing for bone using X-ray/Radiography, with a decision date of June 7, 2024.
2024-06
PMC (via MDPI)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article, published in December 2025, includes the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) among the machine learning-enabled medical devices authorized by the FDA in 2024 for pediatric bone age assessment.
2025-12
Innolitics
Command Line as a Medical Device (CLaMD)
This article from May 2025 mentions the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) in the context of devices that do not have a typical user interface, explicitly stating its output is a JSON message for integration with other systems.
2025-05
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code
The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is listed under the FDA product code QIH for Automated Radiological Image Processing Software, with its clearance date as June 7, 2024.
2024-06
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This article from September 2025 references the EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) in its discussion of ground truthing methodologies, noting that its performance was measured against ground truth from four U.S. board-certified expert radiologists.
2025-09

Videos

Product demos, reviews, and walkthroughs for EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100).

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Frequently Asked Questions

The BAP-XR-100 is designed to assist pediatric radiologists in viewing and quantifying bone age from 2D Posterior Anterior (PA) left-hand radiographs for patients aged 2 to 16 years. It utilizes deep learning techniques to analyze these images according to the Greulich-Pyle method.
The BAP-XR-100 is a Class II medical device that has received 510(k) premarket notification clearance (K234042) from the U.S. FDA. It is designed, verified, and validated in compliance with 21 CFR Part 820.30 (Quality System regulation) and ISO 14971:2019 for risk management.
The system is an adjunct tool and its results should not be solely relied upon for diagnostic decisions, as it does not replace a clinician's judgment. It is intended for patients aged 2 to 16 years and requires specific image quality, such as a fully visible left hand and wrist without major artifacts.
AI-based systems for bone age assessment, including similar deep learning models, have shown high consistency and accuracy comparable to qualified physicians, often reducing variability found in manual methods. While specific comparative accuracy data for BAP-XR-100 against all alternatives isn't detailed, AI tools generally improve radiologist performance when used as an adjunct.
Traditional methods include manual assessment using the Greulich-Pyle (GP) and Tanner-Whitehouse (TW) atlases. Several other commercial AI-based systems are also available, such as BoneXpertu00ae, Physisu00ae, and VUNO Medu00ae-BoneAge, which offer automated bone age estimation.
The BAP-XR-100 is explicitly an aid, and pediatric radiologists are the intended users who must integrate the AI's quantification with their own review of the radiographs and clinical judgment. While AI tools aim to reduce interpretation errors, there is a recognized concern about automation bias, underscoring the importance of the physician's ultimate diagnostic responsibility.
Specific pricing details for the BAP-XR-100 are not publicly available in the provided search results. However, similar AI bone age assessment software often operates on a 'paid per analysis' model, which can be cost-effective for integrating into existing workflows.

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