USFDA Approval?


    I realize this question does not apply to everyone, but in the US it seems that PACS are classified as Medical Devices and, as such, subject to USFDA approval. I'm not entirely clear on the differences between a DICOM store, mini-PACS and PACS so I wanted to ask if Orthanc has USFDA approval and (assuming it does not) if anyone is using Orthanc in the US and if this is a concern?


Dear Joshua,

Orthanc is neither FDA-, nor CE-approved so far.

We are investigating what are the steps towards getting the “FDA 510k clearance”, but this is a long process (e.g. it took 2 years for ClearCanvas to get such a clearance [1]). Any help/suggestion/experience about FDA certification would be extremely useful to us!

It is important to notice that the open-source Orthanc product does not and will never embed tools for image interpretation, and does not modify the DICOM images it receives and stores (this is what we mean by “lightweight PACS”). It is therefore possible that full 510k clearance is not required, but we need to gather additional legal inputs from US administrations.



Hello Sébastien,

   Thank you for responding. The research I have been doing into this seems to follow your comment that the USFDA certification is focused around the viewing and manipulation of the images and not the storage. But I can't say for sure as I'm not a lawyer. None the less, I'll follow up to this thread with any additional information I find out.

Thanks again.