DCM4CHEE LEGAL ISSUES

USA:

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act.

DCM4CHEE falls into Class I, intended as Medical image storage device (892.2010) and Medical image communications device (892.2020),  using LOSSLES compression  is exempt from 510(k) premarket notification procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.2010

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.2020

CE:

In CE DCM4CHEE usign LOSSLESS compression even falls out of the Medical Device Clasification.

(i) In relation to PACS (a) intended by its manufacturer to be used for viewing, archiving and transmitting images, it is considered that applying rule 12 could be appropriate and accordingly this type of PACS are generally classified as Class I medical devices. However, PACS that are only intended for archiving or storage of data may not fall within the definition of a medical device provided that data is not manipulated.

http://ec.europa.eu/consumers/sectors/medical-devices/files/wg_minutes_member_lists/version1_9_borderline_manual_en.pdf