Orthanc FDA approved?

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1

Is orthanc a clinically compliant option for use in hospitals?

A google search shows me that the Osimis viewer is not FDA cleared?

But is the Orthanc service clear since PACS systems are no longer (since 2021) considered to be a medical device and thus don’t need 510(k)?

Is there an FDA approved Viewer that can be used as plug in for Orthanc?

Appreciate any clarifications!

2

There is a list of open source viewers and tools listed here:

https://book.orthanc-server.com/faq/viewers.html

As for FDA or otherwise certified viewers, there are not that many on the lower end of the scale. MedDream and OSIRIX come to mind. HOROS is open source and basically very similar to OSIRIX, but is doesn’t have FDA approval yet. Radiant is pretty decent for the price, but I do not believe that is ‘certified’ in the US or the EU either. Generally speaking, you have to pay a decent premium to get an FDA approved viewer.

Stephen D. Scotti, M.D.

3

Hi thanks for the response!

Can you confirm that the DICOM server / database itself is not considered an FDA medical device?

For the viewer, I have looked into MedDream and Osirix and may go that route. Though from the wording of the 2021 changes from PACS to MIMPS it seems that viewers (“displays”) are no longer considered medical devices… so why would they need FDA clearance?

Thanks again for the info.