Disclaimers

Data privacy

Please see Axceptio module for more information on how we process personal data and comply with GDPR. 

Product disclaimers

In Europe:

BoneView and ChestView are Class IIa medical devices manufactured by Gleamer and whose conformity assessment has been carried out by the notified body KIWA CERMET CE 0476 relatively to 93/42/CEE directive. It is intended to provide preliminary data for helping physicians’ diagnosis of body X-rays. Please read the instructions for use carefully. 
Instructions for use are available at the following address:

https://confluence.external-share.com/content/bc363230-fb30-440a-884c-fa544f4110c0

In the US:

BoneView is a class II medical device that has been cleared by the FDA under K212365. BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs. For more information on precise indications for use, warnings, and limitations of the software, refer to the 510(k) summary available on FDA’s website. Please read the instructions for use carefully. 
Instructions for use are available at the following address:

https://confluence.external-share.com/content/ad9682a8-9fbb-4530-9c45-78957f3fffc3

Other Quality Management information

Our company is certified with ISO 13485:2016