Please see Axceptio module for more information on how we process personal data and comply with GDPR.
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:
Pending 510(k), not available for sale in the United States.
Other Quality Management information
Our company is certified with ISO 13485:2016