The standalone Windows™ software OnyxCeph³™ is a client/server network application developed by Image Instruments for the patient-related management of 2D and 3D image data that can be used for archiving, measurement, planning and consultation purposes in the context of orthodontic treatment. Over the past 20 years, OnyxCeph³™ has established itself as the standard image management system in many orthodontic treatment facilities worldwide.
OnyxCeph³™ includes features (measurement functions) that can be used to aid in diagnosis. In many countries, this requires classification and labelling as medical device software (SaMD). This labeling (e.g. by the CE mark) refers exclusively to the measurement functionality provided in modules Digitize 2D and Digitize 3D in accordance with the intended 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. The information provided in the context of clinical use can only be used for the purpose of validating independent treatment decisions.

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 of the human cranial region 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 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 support and validation of diagnostic and therapeutic decisions.

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.

OnyxCeph³™ is a software only device and 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 who have received dedicated training for use of the software.
Clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.
The classification as a medical device cannot be transferred to treatment measures or the manufacture of orthodontic appliances, even if these take into account the calculation results of the software.

The clinical performance of OnyxCeph³™ software refers to its ability, based on its technical and functional characteristics, to manage and analyze digital images for the purpose specified by the manufacturer, Image Instruments, so that, when used as intended and in accordance with the manufacturer's instructions, it can provide clinical benefit to patients in the form of a positive impact on patient management

The clinical benefit intended by the intended use of the OnyxCeph³™ software is to achieve positive effects on patient management by means of digital management and evaluation of case-relevant digital images, e.g. in the form of savings, facilitation and improvements in the areas of case diagnostics, case planning and patient counseling.

OnyxCeph³™ is a native Windows™ client/server network application for use within an administered IT infrastructure.
From the inputs (case-related image data and additional information) received via interfaces [VDDS; CLI/HTTP; GUI] under user control, visual and graphical outputs (case-related information) are derived internally according to user specifications using implemented algorithms and displayed or output as a file via interfaces.
This information cannot be used directly for treatment purposes, but must be interpreted together with information from other sources by professionally qualified personnel and processed before further use.