The Windows™ software OnyxCeph³™ is a network application developed by Image Instruments for the use of digital 2D and 3D image data for measurement, consultation, documentation and processing purposes in orthodontic workflows.
OnyxCeph³™ is not a Picture Archiving and Communication System (PACS). The software is not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect. However, it does include features (measurement functions on digital images) that can be used to support diagnostic statements. For this reason alone, Image Instruments qualifies and labels the software as medical device software (SaMD).
This labeling (e.g. with the CE mark) refers exclusively to the measurement functionality provided in the Digitize module in accordance with the medical purpose specified by the manufacturer in the instructions for use.
The software does not make treatment decisions or provide treatment recommendations. The software itself and its outputs cannot be used directly on patients or for their treatment. In accordance with its medical purpose, the information provided can only be used to support independently made diagnostic statements

The OnyxCeph³™ software is designed by the manufacturer Image Instruments exclusively to enable orthodontic facilities to achieve clinical benefits in the form of a positive impact on practice and patient management through partial digitization of analogue image-based workflows.
Among other features, the software provides options for measuring distances and angles on the digital images of dental, skeletal and soft tissue structures provided by imaging systems and for calculating variables that can be derived from them on the basis of user input. The digital outputs in the form of displays, files, or printouts do not represent clinical data. Rather, these outputs must be post-processed by the professionally qualified user and interpreted with regard to the specifics of the imaging and patient situation, including other case information, in order to be used additionally, but never primarily or exclusively, for the verification of diagnostic assessments.

OnyxCeph™ must not be used to make diagnoses. The digital image measurement functions provided in OnyxCeph™ are only intended to verify diagnostic statements made using other methods. The interpretation of measurement results on digital images must be based on the user's clinical knowledge and experience.
The software does not recognize anatomical structures. Due to the unknown imaging parameters of the imaging system used, it cannot be assumed that the values measured for distances and angles on patient images and the computations derived from them can be transferred to the patient's anatomical (dental, skeletal, soft tissue) structures depicted. Appropriate interpretation of the measured values determined from the image in the context of the overall findings is therefore always the responsibility of the qualified user's professional expertise.
The correctness of the measurement algorithms used for 2D and 3D data sets can be verified by evaluating the test images provided in the root directory of the installation medium.

OnyxCeph³™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only.
The use of OnyxCeph³™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

The OnyxCeph³™ software is intended for the medical purpose of digitally geometrically measuring patient images in the Digitize module in order to verify diagnostic statements derived from other procedures for the assessment of clinically relevant (classified as disease or disability) dental and jaw misalignments based on the measurement results displayed in the results table of this module.
The software may be used for this purpose only by qualified personnel. Clinical decisions must not be based primarily or exclusively on the evaluation results provided by the software.

The clinical performance of the Digitize module refers to its ability — based on the technical and functional characteristics resulting from the analysis of digital images — to fulfill the intended purpose specified by the manufacturer, Image Instruments, such that, when used as intended [in accordance with the manufacturer’s instructions], clinical benefits for patients can be achieved in the form of positive effects on patient management.

The clinical benefit sought through the intended use of the OnyxCeph³™ Digitize module is to achieve positive effects on patient management through the digital analysis of case-relevant patient images, e.g., in the form of cost savings, streamlined processes, and improvements.