gwolfe2208
Starting to get Involved
My company has a "device" that is a software platform that hosts applications used by radiologists. The platform is used for account management and configuration and does import and export DICOMs. We currently have it classified as a Class I device for the EU. I am having doubts that it should even be considered a medical device. Our customers, hospitals, would use this platform that hosts the application that would be used with their PACs system to view images. The radiologist would then make their diagnosis based on their review. Does anyone have any thoughts?