What about a CE-MARK?
Our Services are not ment to establish a diagnose or to transfer responsibilty. The focus of our Services is anonimization to facilitate discussion and education. Our webviewer does not adhere to any diagnostic standard and specifically not to the Grayscale Standard Display Function – DICOM Standard. This makes it non-diagnostic.
Medical Sofware
Do you have a CE-certification
No. Rad2Share’s intended use and functional capabilities are not diagnostic, but educational.
How so?
The intedend use is to facilitate discussion concercing anonymized medical images through communication and education.
Was this checked?
Yes. We act also according to the new Medical Devices Regulation (MDR), adopted by the European Parliament and Council in May 2017. The new EU MDR, with a mandatory compliance date of 26 May 2020, replaces the former Medical Device Directive (MDD),
Can I use it for a second opinion?
No. Rad2Share’s images, Website and Client are not diagnostic.
Only use original diagnostic images in an appropriate diagnostic setting when considering or performing a second opinion.
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