Medical Device PACS (Picture Archiving and Communication) - Class I or Class IIa?
I'm having difficulty classifying our PACS in accordance with the Medical Device Directive.
Our system is indicated for the transmission, storage and viewing of medical image data, store and manipulate information associated with the image data, store and view testing results, and present a formatted presentation of the stored data and information.
According to the directive in order for a PACS to be a class IIa, the intent would have to include direct diagnosis or monitoring of vital physiological processes. While our 'Intended Use Statement' doesn't mention the word 'diagnosis', this word is mentioned in our risk analysis studies.
Should such a device be a Class I or IIa?