Beam Energy Level
60 kVp
80 kVp
100 kVp
120 kVp
Skin Dose Reduction
65%
51%
44%
39%
• Personal protection as per Guideline 89/686/EEC (Category III, tested as per
EN420:2003+AI:2009, EN374-2:2003, EN374-3:2003 und EN388: 2003), CE 0086
• Medical product as per the European Guideline 93/42/EEC (CE Class IIa, tested per EN455-1:2000, EN455-2:2009+A1:2011, EN455-3:2006, EN455-4:2009), CE 0086
• ASTM D3577
• EN 61267:2006, EN 61331-1:2002, EN 421:2010
Quality Assurance
Manufacturing process is in compliance with the following regulations:
• BS EN ISO9001
• BS EN ISO13485 Qualitätssysteme
• US FDA Quality System Regulation (QSR)
Beam Energy Level
60 kVp
80 kVp
100 kVp
120 kVp
Skin Dose Reduction
62%
53%
46%
40%
In compliance with EN 420, EN 374-2, EN 388,IEC/EN61331-1 Radiation quality acc to IEC 1267 /EN61267, RQR qualities (Al-filtration), ICRUSl (International Commission on Radiological Protection)
Manufacturing process is in compliance with US FDA Quality System Regulation (QSR) and BS EN IS09001 Quality System RadiaXon®is an approved product of OSHA, Germany
Beam Energy Level
60 kVp
80 kVp
100 kVp
120 kVp
Skin Dose Reduction
51%
48%
37%
32%
In compliance with EN 420, EN 374-2, EN 388,IEC/EN61331-1 Radiation quality acc to IEC 1267 /EN61267, RQR qualities (Al-filtration), ICRUSl (International Commission on Radiological Protection)
Manufacturing process is in compliance with US FDA Quality System Regulation (QSR) and BS EN IS09001 Quality System RadiaXon®is an approved product of OSHA, Germany