CR_10-X_ - AGFA | 合法醫療器材資訊網

CR_10-X_-1.CR10-XDigitizersafetyCR10-XDigitizerCR10-XDigitizerWhyAgfaHealthCare?RegionRegulationX-rayLaserEuropeEN/IEC60601-1 ...

CR 10-X Digitizer safety CR 10-X Digitizer CR 10-X Digitizer Why Agfa HealthCare? Region Regulation X-ray Laser Europe EN/IEC 60601-1 edition 2 Regulation: 1987 EN 60825 - 1:2001 EN/IEC 60601-1 edition 3 EN/IEC 60601-1-2 USA UL 60601-1 DHHS/FDA 21 CFR DHHS/FDA 21 21CFR part 820: good part 1002, subchapter B CFR parts 1040, 10 manufacturing practice for CSA22.2 No.601.1 No.601.1.2 CR 10-X medical devices Canada Digitizer EN 60825 - 1:2007 and 1040, 11 Agfa HealthCare is a global leader in the fast growing market of integrated IT and imaging systems, offering healthcare facilities a seamless flow of information and a 360˚ view of patient care. The company has a unique, holistic approach, enabling it to provide in-depth clinical know-how and fully integrated hospital-wide solutions. These specialized solutions integrate IT and imaging systems for Radiology, Cardiology, Mammography and Orthopaedics. Agfa HealthCare’s en...