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Thursday, June 20, 2013
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Comments
Use as a medical device by: Anonymous on 12/1/2009
OsiriX Mobile is a very good iPhone App which utilises the capabilities of a mobile device for physicians. It's a perfect partner for the "big" OsiriX software.


There is no FDA-cleared CE-marked version of OsiriX Mobile available. Which makes it difficult to specify professional usecases for the software.

In most industry nations the use of software for medical purposes for patients, in diagnosis, therapy or surgery is considered as a medical device. For example: in terms of classification, OsiriX is a class II medical device in the European Union and the USA.

aycan is offering OsiriX PRO as an FDA-cleared and CE-labeled version of OsiriX as medical device class II with support and comprehensive documentation.

Stephan P0pp
http://www.aycan.de
Too late for mine by: Anonymous on 12/1/2009
If this would have been around three years ago, it might have saved me many hours of pain.

Interesting article.
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