ISO 13485:2016 Certification

CE Mark Certification

UL Listing

Inspection Body ISO 17020:2012 Accreditation

SOUTH AFRICA
Medical Device Licenses

CANADA
Medical Device Licenses

EUROPE
CE Marking Certificates

NOTE: The Lodox Xmplar-dr and eXero-dr are medical devices certified in the European Union under the Medical Device Regulation (EU) 2017/745 by SGS CE1639, exclusively for the clinical indication(s) of full-body, low dose, x-ray scanning which produces digital X-ray images used for diagnosis purposes in both trauma and general radiography. Please note that other non-clinical indications of this device, such as forensic pathology applications, are outside the scope of CE Certification as medical devices, and users should be aware that the product’s performance and/or safety has only been evaluated by SGS for the medical purpose.

UNITED STATES
FDA 510(k) Cleared / PMA Approved Devices
UL Listed