en:specification
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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, | 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, | ||
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=====Indications for Use===== | =====Indications for Use===== | ||
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.\\ | 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, | The use of OnyxCeph³™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, | ||
The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. [[indication_for_use|{{: | The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. [[indication_for_use|{{: | ||
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=====Medical Purpose===== | =====Medical Purpose===== | ||
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.\\ | 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.\\ | 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. [[indication_for_use|{{: | 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. [[indication_for_use|{{: | ||
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===== Performance Data ===== | ===== Performance Data ===== | ||
en/specification.1711033956.txt.gz · Last modified: 2024/03/21 16:12 by onyxadmin