Please see Axceptio module for more information on how we process personal data and comply with GDPR.
BoneView is a Class IIa medical device 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 information for diagnosis on standard radiography. Please read the operating instructions carefully.
Pending 510(k), not available for sale in the United States.
Other Quality Management information
Our company is certified with ISO 13485.