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Traditional 510(K) - Software - Clinical testing?


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!


Staff member
Super Moderator
Is this "software as a medical device" (i.e., stand-alone software that is, of itself, a device)?

Regardless, IEC 62304 is a recognized consensus standard so if you've followed that, it should be a matter of compiling info you have.

Some guidance docs you might find helpful:

Content of premarket submission:
Software... clinical validation:

That said, FDA is VERY focused on cybersecurity right now so just complying with 62304 may not be completely sufficient. Here are a few more guidance docs to consider:

Premarket (VERY recently put out):
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