Hello Everyone,
I am very new in FDA processes. I would like to submit a traditional 510k to our software (almost the same as syngo VD11). We already have a CE mark, so we have a ton of documents, sometimes I don't understand the differences between the two system.
Electromagnetic Compatibility and Electrical Safety - I would say a software doesn't have electrical components so this is not applicable
clinical, animal and bench testing - which one is applicable? We have all of them, should I submit them?
Thank you in advance!
I am very new in FDA processes. I would like to submit a traditional 510k to our software (almost the same as syngo VD11). We already have a CE mark, so we have a ton of documents, sometimes I don't understand the differences between the two system.
Electromagnetic Compatibility and Electrical Safety - I would say a software doesn't have electrical components so this is not applicable
clinical, animal and bench testing - which one is applicable? We have all of them, should I submit them?
Thank you in advance!