CephNinja
Cyncronus LLCCephNinja is a software tool designed for dental professionals to assist in orthodontic treatment planning and case diagnosis by enabling cephalometric tracing and analysis of lateral cephalometric x-ray images. It operates on macOS and iOS platforms, supporting 2D image visualization and detailed landmark digitization but requires interpretation by trained practitioners. The software is not intended for standalone diagnostic use, especially its mobile version.
Intended Use
CephNinja software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis.
Technology
Software-only medical image processing system that operates on macOS/iOS; allows digitization of landmarks on lateral cephalometric x-rays, tracing of structures, cephalometric analysis, and image visualization in 2D.
Performance
Extensive software validation including software verification and validation, risk management per ISO 14971, IEC 62304 compliance, cybersecurity testing, and non-clinical bench testing comparing software results to manual tracing with measurement differences within clinically acceptable thresholds (<2 degrees and <2 mm).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/24/2024
7 months - 2
FDA Approval
1/23/2025
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