FDA Clearance

[Spiney]

I'm currently in the process of using the dicom toolkit to create some software for archiving other PAC Systems. I was wondering if anyone has tried to get the dcmtk FDA cleared or if it is even needed.

I thought that the dcmtk was going for FDA clearance, but I couldn't find it on the forums again.

Thanks in advance

[Per]

Yes, we have. It is your responsibility as vendor to validate DCMTK as a software of unknown provenance and to do a risk assessment of it in context of how you use it. You can find guidance on how to do this on the FDA web pages.