Visiogenics UG (haftungsbeschränkt)
Bettinastrasse 30
60325 Frankfurt am Main, Germany
Our company offers a visualization of the cavitations in the area of the jaw on the basis of CBCT (3D volume tomography images). This is done for research and approval purposes prior to the planned launch of a medical device. In this context alone, we offer services in the sense of method validation. The visualizations we provide are one possible representation of the bony situation in the jaw in many cases, not the only possible representation or even a final assessment or diagnosis of the actual conditions. Our service and the software we use do not represent a diagnostic tool or even a treatment recommendation, i.e. no diagnosis or treatment specification is created. It is the sole responsibility of the attending dentist, oral surgeon or maxillofacial surgeon to determine the actual situation by examining and analyzing the CBCT (computed tomography 3D images) available to him and to make his own diagnosis and treatment recommendation based on this. Our visualization cannot replace, in whole or in part, such independent diagnosis and treatment recommendation by the treating dentist, oral surgeon or maxillofacial surgeon. The visualizations are provided for general informational and educational purposes only and are not a substitute for professional advice. We do not offer such medical/health advice.
The visualization software we use does not (yet) have FDA approval in the USA or a CE mark because the necessary approval procedures are still ongoing. The outcome of these procedures is open. The visualization we provide therefore does not constitute the placing on the market of a medical device; rather, the test use of the visualization serves to verify the reliability, accuracy and usability of the results of our visualization software. As this has not (yet) been positively confirmed, the results of our visualization cannot be used as a basis for assessing actual conditions in the jaw or other parts of the body, as it is unclear whether and to what extent the visualization provides or can provide a reliable and usable image of the actual conditions.
As part of the studies we conduct, Visiogenics can carry out a follow-up check on the reliability, accuracy and usability of the results of our visualization software from oral surgeons or maxillofaical surgeons and the the treating dentist.
As diagnosis and treatment planning are the sole responsibility of the treating dentist, oral surgeon or maxillofacial surgeon, no liability can be accepted for the outcome of dental or jaw treatment. In particular, we give no express or implied assurance or guarantee regarding the accuracy, appropriateness, value, reliability, availability or completeness of the results of the visualization provided by our service.
IN NO EVENT WILL WE BE LIABLE TO YOU FOR ANY LOSS OR DAMAGE OF ANY KIND INCURRED AS A RESULT OF THE USE OF OUR VISUALIZATION APPLICATION OR RELIANCE ON ANY INFORMATION PROVIDED IN OUR VISUALIZATION APPLICATION. USE OF OUR VISUALIZATION APPLICATION AND RELIANCE ON THE INFORMATION IN OUR VISUALIZATION APPLICATION IS SOLELY AT YOUR OWN RISK.
PROFESSIONAL DISCLAIMER
The visualization software cannot and does not provide medical/health advice. The medical/health information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, we recommend that you consult the appropriate professionals before taking any action based on this information.
We do not provide medical/health advice. USE OR RELIANCE ON ANY INFORMATION CONTAINED IN OUR VISUALIZATION APPLICATION IS SOLELY AT YOUR OWN RISK.
Secure Communication
In order to ensure the confidentiality and integrity of information transmitted, we utilize secure communication channels.
All communication is conducted via secure legal communication channels, ensuring the encryption of data transmission.
We conclude separate confidentiality agreements with each participating dentist, and, if necessary, agreements on order processing in accordance with the GDPR.
[ ] By commissioning us, you agree to the above provisions.
Visiogenics UG (haftungsbeschränkt)
