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--- en:indication_for_use [2024/03/14 14:13] – onyxadmin
+++ en:indication_for_use [2024/04/09 12:36] (current) – [Intended use environment] onyxadmin
@@ Line 1: / Line 1: @@
 ======Intended use environment======
 -----
+===== Device Description =====
+The standalone Windows™ software OnyxCeph³™ provides software tools to digitally perform analog image-based in-house workflows in orthodontic facilities. To the extent that these workflows output measurement information, their accuracy shall at least match the accuracy of the corresponding analog workflows.\\
+The tools developed for this purpose shall be flexibly configurable and combinable in order to digitally map a wide variety of orthodontic in-house workflows and thus generate a general benefit in the form of savings, facilitation and improvement.\\
+In addition to this general benefit, the application of the software enables a clinical benefit exclusively in the form of deriving metric information from case-relevant 2D and 3D image data and is therefore classified as a medical device.\\
+The OnyxCeph³™ 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. According to the intended purpose, the measured values provided within the scope of clinical use can only be used to back up independently made treatment decisions.\\
+\\
 <WRAP formalbox>