We have produce gamma camera and PET systems since 1981 for the complete nuclear imaging medical market of the nuclear medical diagnostic. We provide for the discriminating and price sensitive market.
All our systems are manufactured and remanufactured* according to current medical and technical requirements. The experience and the know-how since 1974 form the development of our data and image processing unit SCINTRON. This diagnostic prospects are also available for the veterinary market.
Accredited service, constantly care of our hard- and software and time accordant design show our capacities.
Since 1995 MiE America, Inc. has been in business to provide a better service to our america customers. Located is MiE America, Inc. in Elk Grove Village, IL, USA.
The MiE GmbH is in accordance with EN ISO 9001:2008, EN ISO 13485:2012 + AC: 2012 certified and our gamma camera systems are with Annex II of Directive 93/42/EWG approved. Also, we are registered as Remanufacturer* of medical devices at the FDA - our systems are 510(k) approved since 1995. This extensive certification is the basis for the manufacture and distribution of medical products on the world market.*Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Source: [CITE: 21CFR820.3] Definitions(w)