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 require classification as medical device software (SaMD) in many countries. The measurement functionality can be used in all modules.
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.

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 correct function of the software requires the use of the most up to date program version (release). The availability of a new program version is displayed by a release update button top right in the program main window if online connected. Alternatively, the update information has to be checked on the product website www.onyxceph.com on a regular base.
The intended use of the software requires the proper registration and productive activation of the software by the user. Non-productively activated versions of the software only serve to familiarise the user with its use or for testing purposes.

Release history

All image managementt and image evaluation tools provided by OnyxCeph³™ merely serve to assist you in finding a diagnosis. All diagnosis and possible treatments must be based on clinical knowledge and experience. OnyxCeph³™ does not lay claim to replace the diagnosis of the physician.
Additionally, it is pointed out that the results obtained by the measuring functions of OnyxCeph³™ can only be correctly calculated on condition of the object to be evaluated being digitally imaged in the focal plane without distortion. This has to be secured by means of appropriate calibration of the image acquisition process or suitable correction of the digitally recorded images.
The propriety of the used algorithms for 2D and 3D measurements on data sets can be verified by both test images which can be loaded from the root directory of the installation medium and download installation zip file. Both test images have to be classified as image type NoType (2D) resp. NoType (3D) and analyzed by the Calibration analysis. The error of each such measurement should be within the standard deviation displayed in column norm value.

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