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Varex Imaging Corporation is currently registered or certified under the following regulations and standards:

  • ISO 13485
  • Varex holds an EC certificate under the requirements of Council Directive 93/42/EEC
  • Canadian Medical Device Regulation, P.C.
  • ISO 9001
  • UL/IEC 60601-1
  • CSA 22.2 No. 601.1
  • CFDA
  • Chinese SFDA Registration Nos. 0712278, 0714670, 0004482
  • Japanese PAL/Yakuji-Ho: Controlled MD
  • Russian MHSD: Federal Law No. 184-FZ
     

Salt Lake City, UT

  • FDA 21 CFR, Sub-Chapter J. Initial report number 7410266
  • ISO 9001 Certificate Number FM21804
  • ISO 13485 Certificate Number FM77566
  • CE Mark Certificate Number CE 00999
  • Canadian Medical Device Regulations (CMDCAS)

 

Las Vegas, NV

CE Marking: All Linatron® M™ and K15A™ models are designed, manufactured, and are in conformance with:

  • IEC/EN 61010-1
  • ANSI/UL 61010-1
  • CAN/CSA C22.2 NO. 1010.1-92
  • EMC Directive 2014/30/EU
  • Low Voltage Directive (LVD) 2014/35/EU
  • EN 55011/CISPR 11
  • 2014/35/EU Low Voltage Directive
  • 2014/30/EU EMC Directive


Quality Standard: Varex Imaging Corporation, Las Vegas facility, Quality Management Systems is registered to ISO9001:2008. 
 

Charleston, SC

  • FDA 21 CFR, Sub-Chapter J. Initial report number 8612039
  • ISO 13485 Certificate Number FM84906
  • CE Mark Certificate Number CE 00999

 

Willich, Germany

  • ISO 13485 Certificate Number FM84906
  • CE Mark Certificate Number CE 00999

 

Beijing, China

  • YY/T 0287 Certificate No. 04709Q10016ROS-1
  • Beijing Hua Guang Certification of Medical Devices Co. Ltd. (CMD)


Varex Imaging Corporation complies with requirements of:

  • WEEE (Waste Electrical and Electronic Equipment) Directive 2002/96/EC
  • RoHS (Reduction of Hazardous Substances) Directive 2002/95/EC
  • Administrative Measure on the Control of Pollution Caused by Electronic Information Products, No. 39 (February 2006—People's Republic of China) SJ/TI 1364-2006