New Radiant Technology, since its beginning, works in regime of Quality Management System 

Certificate no. 9120.NRT1 Conforms with standard ISO 9001:2008 / ISO 13485:2003

In particular, Novac7 is a Class I, Type B equipment according to the requirements of IEC 60601-1 standard, it is also a medical device according to directive 93/42/EEC Class II B and, the following directives:

• IEC 60601-1:1988 + A1 + A2 + US/CAN deviations - Electromedical equipment. Part 1: General Safety Regulations.
• IEC 60601-1-2:2001 + A1:2004 Electromedical equipment. Part 1: General Safety Provisions. Collateral Standard: Electromagnetic compatibility – prescriptions and tests.
• IEC 60601-1-4: 1997 + A1: 1999  Electromedical equipment. Part 1: General Safety Regulations. 4. Collateral standard: Programmed electromedical systems.
•  IEC 60601-2-1: 1998 + A1: 2002 Electromedical equipment. Part 2: Special safety rules concerning medical accelerators using electrons ranging from 1 MeV to 50 MeV.

Novac7 also possesses

• 510(k) Number 990209 FDA APPROVAL

• cTUVus Certification no. 72101464.01 and report n° 30993344.001

Patents

Italy Patent number 1317944

Europe Patent number 0702982 (1° aggiornamento) 1317944 (2° aggiornamento)

USA Patent number 5,635,721