AudaxCeph Cephalogram Analysis Software
Audax d.o.o.AudaxCeph Cephalogram Analysis Software is a specialized software intended for dental professionals to assist in treatment planning by analyzing 2D cephalogram images. It automatically detects landmarks on images, allows measurement and superimposition, and supports orthodontic treatment planning. The software can be used as a desktop application or via the cloud, helping clinicians make informed decisions by digitizing and analyzing dental radiological images efficiently.
Intended Use
Designed for use by specialized dental practices for storing and presenting patient images and assisting in treatment planning. Results produced by the software's treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Technology
Software-only device that analyzes 2D cephalogram images input in common image formats. It digitizes landmarks, traces structures, measures distances, provides superimpositions and visualized treatment objectives. Available as locally hosted or cloud-hosted application, it supports orthodontic treatment planning through automatic landmark detection and custom analyses.
Performance
Non-clinical testing including unit, performance, manual, integration, system and regression testing were performed and met acceptance criteria. Automatic landmark detection accuracy was validated against manual landmark placement and passed acceptance thresholds. Clinical performance testing was not required to demonstrate substantial equivalence with the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
8 months - 2
FDA Approval
5/30/2025
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