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AudaxCeph Cephalogram Analysis Software

by Audax d.o.o. · Based in Slovenia → — AI-powered Cephalometric Analysis Software for Orthodontic Excellence

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Regulatory Status Disclosed

Overview

AudaxCeph Cephalogram Analysis Software is an advanced, AI-powered solution designed for dental professionals, particularly orthodontists, to streamline and enhance cephalometric diagnostics and treatment planning. The software automates the tedious process of cephalometric tracing, accurately detecting and placing between 70 and 100 soft and hard tissue landmarks on lateral or PA cephalometric radiographs in seconds. This significantly reduces the time required for analysis, allowing clinicians to focus more on patient care.

AudaxCeph offers comprehensive tools for various orthodontic analyses, superimpositions, STO/VTO (Visualized Treatment Objective), and growth prediction. It also includes robust features for document and photograph management, enabling efficient organization of all treatment-related files in timeline containers. The software supports customizable analysis types, allowing users to choose from over 200 existing types or create their own tailored measurement protocols. AudaxCeph is available as a desktop application and a cloud-hosted solution (WeDoCeph), providing flexibility in deployment.

Beyond diagnostics, AudaxCeph assists in patient communication by enabling the creation of presentations to show treatment progress and simulations. The software is MDR certified and FDA 510(k) cleared (K243005), with Audax d.o.o. maintaining a certified Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

Automated Cephalometric Tracing
AI-powered Landmark Detection (70-100 points)
Cephalometric Analysis (Lateral and PA)
Superimpositions (Structural and Analyses)
VTO (Visualized Treatment Objective) & Growth Prediction
Treatment Simulation & Planning
Document and Photograph Management
Customizable Analysis Types (200+ templates)
Report Generation (PDF, Excel)
DICOM Support
Image Enhancement Tools
Multi-language Support

Use Cases

Orthodontic treatment planning and diagnostics
Analysis of 2D cephalogram images
Skull growth projections and predictions
Patient education and treatment presentation
Efficient organization of patient records and images
Support for maxillofacial surgery planning

What Physicians Need to Know

Evidence Base

AudaxCeph is MDR certified and FDA 510(k) cleared, classified as a Class IIa medical device. It maintains a Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001. The software's analysis capabilities are deemed substantially equivalent to the predicate device, CephX Cephalometric Analysis Software. The accuracy of its automatic landmark detection was evaluated against acceptance criteria established through studies of manual landmark placement and a literature review. It offers a library of over 200 analysis types, including established protocols like Ricketts, Bju00f6rk, Steiner, and Tweed, and allows for customization.

Clinical Validation Studies

A study concluded that AudaxCeph's AI-driven automatic tracing provides a reliable and accurate method for orthodontic treatment planning across various skeletal types, with minimal discrepancies (under 2mm) compared to manual operators, though variations were noted at Gonion and Porion landmarks, suggesting practitioner verification for less reliable landmark locations. Another comparative study found satisfactory agreement between both automated and semi-automated AudaxCeph versions and the manual method, with mean differences close to zero and approximately 95% of data points within agreement limits. This study indicated that the semi-automated AudaxCeph showed greater agreement and precision. Inter-observer and intra-observer agreements for AudaxCeph, Dolphin, and manual methods consistently showed ICC values above 0.90. Non-clinical performance testing, including software verification and validation, was successfully conducted according to FDA Voluntary Consensus Standards.

Differential Diagnosis Support

AudaxCeph assists in diagnosis by converting X-rays into detailed information for treatment plans, skull growth projections, treatment predictions, and simulations. It provides tools for creating treatment plans based on predicted results (VTO/STO) and helps formalize irregularities to define a course of treatment.

Guideline Update Frequency

While a specific update frequency for guidelines is not stated, AudaxCeph's extensive and customizable library of over 200 analysis types allows clinicians to adapt the software to various established protocols and create personalized measurement protocols, accommodating evolving clinical practices. Its MDR certification and FDA 510(k) clearance imply adherence to regulatory standards that involve ongoing compliance and potential updates.

Clinical Workflow Integration

The software is designed to streamline workflow, saving time through automated landmark detection and tracing, which can place 70 to 100 landmarks in seconds. It enables organization of patient documents in timeline containers and supports importing DICOM files. AudaxCeph offers both desktop and cloud-hosted (WeDoCeph) configurations. It is described as a 'fully open software suite with intelligent document organization' and can integrate with 3D study model analysis via the Audax StudyModel bundle, utilizing a single, integrated database. Patient management features include adding, searching, exporting, and importing patient data.

Decision Audit Trail

AudaxCeph facilitates a level of accountability and record-keeping through its intelligent document organization, where documents are neatly stored on stages of treatment. All data is accessible with adequate authorizations and can be cryptographically protected for enhanced security. Changes made to an analysis, whether at the analysis or superimposition level, are designed to ripple through the system and appear as expected, indicating a form of internal tracking.

Physician Tip

Leverage AudaxCeph's AI-powered auto-tracing for initial cephalometric analysis to significantly save time, but always perform a critical review and manual verification of landmark placements, especially for areas like Gonion and Porion, as indicated by validation studies. Utilize the extensive library of analysis types and the customization features to tailor reports and measurements to specific clinical needs and research protocols. Integrate the software's VTO and growth prediction tools to enhance patient communication and treatment planning, showcasing predicted outcomes and treatment progress effectively.

AudaxCeph offers seamless integration with Audax StudyModel for a comprehensive 2D cephalometric and 3D study model analysis solution, operating from a single, integrated database. It supports importing standard image formats, including DICOM, and can export reports in vector and PDF formats for compatibility with other presentation and documentation tools. The availability of both desktop and cloud-hosted versions (WeDoCeph) provides flexibility for integration into various practice IT infrastructures.

At a glance

Pricing Paid

Deployment Desktop (locally Hosted); Cloud Hosted (WeDoCeph)

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Details

Category	Clinical Decision Support & Reference, Dental AI
Pricing	Paid — Essentials: 1650 € (one-time); Ultimate: 3600 € (one-time)
Deployment	Desktop (locally hosted); Cloud-hosted (WeDoCeph)
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated AudaxCeph Cephalogram Analysis Software (K243005) is a software-only device intended for use by specialty dental professionals in the development of 2D dental treatment planning utilizing cephalogram landmarks. It received FDA clearance on May 30, 2025, and was found substantially equivalent to the predicate device CephX Cephalometric Analysis Software (K231396).
Integrations
EHR	Not specified
Specialties	Dentistry

What the Web Says

AudaxCeph is an orthodontic software suite designed for cephalometric analyses, superimpositions, STO/VTO, and document/photograph management. It utilizes AI-assisted automatic tracing to quickly identify cephalometric landmarks on lateral and PA cephalometric radiographs. The software aims to streamline orthodontic workflows, enhance diagnostic accuracy, and improve patient outcomes. It is available in two editions, Essentials and Ultimate, with different feature sets, and offers a one-time licensing model. Studies suggest that the semi-automated AudaxCeph software offers a robust and cost-effective solution for cephalometric analysis with high accuracy, making it a compelling alternative to other software and manual methods.

Overall: Positive

Strengths

AI-assisted automatic tracing for fast landmark detection.
High accuracy in cephalometric analysis, comparable to or exceeding manual methods and other software in some aspects.
Cost-effective with a one-time licensing model, offering an alternative to recurring subscriptions.
Comprehensive features for orthodontic workflow, including 3D imaging, treatment planning, and patient management.
User-friendly interface and robust data integration.
MDR certified and FDA 510(k) cleared, with ISO 13485 and ISO 9001 certified Quality Management System.

Limitations

Steep learning curve and substantial IT overhead for installation and updates.
Fully automated tracing may have some discrepancies in landmark identification, particularly for certain points like Porion and Gonion, requiring practitioner verification.
Practices primarily needing lateral cephalometric analysis might be paying for unused capabilities in the full version.
Limited information available on G2 and Capterra regarding user reviews and ratings.
Customer support primarily via email.
No specified company size for the target audience, defined by specialty rather than business segment.

Based on reviews from: Capterra, BCeph, SoftwareSuggest, AudaxCeph Official Website, PubMed Central (PMC), G2, SourceForge, PubMed, ResearchGate

Last updated: 2026-07-17

Ratings & Reviews

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Press & Coverage

Innolitics

AudaxCeph Cephalogram Analysis Software Cleared Traditional

AudaxCeph Cephalogram Analysis Software received traditional clearance on May 30, 2025, as an automated radiological image processing software. It is categorized under product code QIH, which includes software implementing artificial intelligence and nonadaptive machine learning algorithms.

2025-05

Radiology AI News Feed

AudaxCeph Cephalogram Analysis Software | FDA Radiology AI News Feed

AudaxCeph Cephalogram Analysis Software, an FDA-cleared radiology AI listing for X-ray/Radiography, was approved on May 30, 2025. This specialized software is designed for image analysis and processing in the Head/Neck region using X-ray/Radiography.

2025-05

FDA

K243005 510(k) Summary - AudaxCeph

This 510(k) summary, dated September 23, 2024 (revised May 30, 2025), details the substantial equivalence of AudaxCeph Cephalogram Analysis Software to the predicate device, CephX Cephalometric Analysis Software. The software is intended for specialized dental practices for 2D dental treatment planning using cephalogram landmarks.

2024-09

PubMed Central (PMC)

Comparative accuracy of artificial intelligence-based AudaxCeph software, Dolphin software, and the manual technique for orthodontic landmark identification and tracing of lateral cephalograms

A study published on March 15, 2025, concluded that the semi-automated AudaxCeph software offers a robust, cost-effective, and highly accurate solution for cephalometric analysis, comparable to or exceeding Dolphin software and manual methods. The study found strong agreement among all methods for measuring orthodontic indices.

2025-03

BCeph

Cephalometric Software Comparison 2026: 12 Programs Compared u2014 Dolphin, WebCeph, CephX & Alternatives

Published on July 9, 2026, this comparison highlights AudaxCeph as a Windows desktop application offering AI-assisted auto-tracing with a one-time licensing model, making it a perpetual-license alternative to cloud-based subscription tools. It supports over 50 analyses and offers local data storage.

2026-07

PubMed

Assessing AudaxCephu00ae's cephalometric tracing technology versus a semi-automated approach for analyzing severe Class II and Class III skeletons

This study, published on October 7, 2024, found that AudaxCeph's AI-driven automatic tracing of cephalograms is a reliable and accurate method for orthodontic treatment planning across various skeletal types and severities. While generally accurate, minor discrepancies were noted at specific landmarks, suggesting a need for practitioner verification.

2024-10

Capterra

AudaxCeph Software Pricing, Alternatives & More 2026

Capterra provides information on AudaxCeph Software, including reviews, pricing plans, and comparisons to other dental charting products. This resource helps potential users evaluate the software's features and value.

2025-11

Videos

Product demos, reviews, and walkthroughs for AudaxCeph Cephalogram Analysis Software.

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Frequently Asked Questions

How does AudaxCeph leverage AI for cephalometric analysis, and what are its primary benefits for a physician?

AudaxCeph utilizes AI for automated landmark detection and cephalometric tracing, which significantly reduces the time required for analysis, often completing it in seconds. This automation streamlines orthodontic workflows, enhances diagnostic accuracy, and provides tools for treatment simulation and growth prediction, allowing physicians to focus more on patient care.

What are the regulatory compliance standards for AudaxCeph, especially concerning its AI components and patient data security?

AudaxCeph is MDR certified and FDA 510(k) cleared, classified as a Class IIa medical device. The manufacturer maintains a Quality Management System (QMS) in accordance with ISO 13485 and ISO 9001, ensuring adherence to high standards for medical device development and data management.

What are the known limitations or potential inaccuracies of AudaxCeph's AI-driven analysis that a physician should be aware of?

While highly accurate, studies indicate that AudaxCeph's automated analysis may show some discrepancies in measurements, particularly for angular convexity and the occlusal plane, compared to manual methods or other software. The semi-automated mode often demonstrates greater precision, and expert clinical oversight remains crucial to minimize potential errors, especially with linear measurements and images with positional errors.

What are the pricing models for AudaxCeph, and are there any recurring fees or subscription costs associated with its AI features?

AudaxCeph offers two main packages: Essentials for u20ac1650 and Ultimate for u20ac3600, with pricing for USA sales requiring direct contact. The software operates on a lifetime license model, meaning there are no obligatory annual fees or maintenance costs to run the software.

What are the main alternatives to AudaxCeph for AI-powered cephalometric analysis, and how do they compare in terms of features and reliability?

Key alternatives include Dolphin Imaging, WebCeph, and CephX, among others like OCS Dental and Dr. Ceph. While many offer AI-driven landmark detection and tracing, comparative studies suggest varying methodologies and occasional discrepancies in specific measurements across different platforms, highlighting the importance of evaluating each software's performance for particular clinical needs.