This device complies with the following international regulations:
Medical Device Regulation (EU) 2017/745, Class IIb.
Directive 2011/65/EU on the Restriction Of use of certain Hazardous Substances in electrical and electronic equipment (RoHS), as amended by Directive (EU) 2015/863.
UK Medical Devices Regulations 2002 (SI 618) as subsequently amended by the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478), Class IIb.
FDA Center for Device & Radiological Health: This product is in conformity with performance standards for diagnostic x-ray systems and their major computed tomography equipment under 21 CFR 1020.30, and for computed tomography equipment under 21 CFR 1020.33, except with respect to those characteristics authorized by Variance Number FDA-2018-V-1901 effective June 15, 2018 (USA).
Radiation Emitting Devices Act - C34 (Canada).
Medical Devices Regulations (Canada).