Specification
Device Description
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 [read more...].
Performance Data
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.
Program Versions | Modules
| Topic | Content |
|---|---|
| Program Versions | Available program versions |
| Version Featurelist | Program version comparison |
| Module List | Available software modules |
| Module Windows | Module Windows overview |
