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RadiAnt DICOM Viewer - Discussion Forum
FDA/CE certifications

Jan 5, 2017 01:23 PM
by nnn

Do you plan to make Radiant DICOM Viewer FDA/CE certified?

Currently in the manual we can read that "RadiAnt DICOM Viewer is not a medical product. It has no FDA/CE or any other certifications and is not intended for diagnostic purposes."

Any plans in this direction?

Jan 5, 2017 01:38 PM
by @radiant
I think now is the time to do it.
Jan 8, 2017 12:55 PM
by RadiAnt
There are some plans regarding this matter but nothing specific can be shared at this moment.
Jan 10, 2017 07:41 PM
by nnn
We plan to buy some RadiAnt licenses (including RadiAnt CD/DVD) and we want to use it for medical purposes in a hospital. I hope that you will make some steps in near future.

May 29, 2017 11:17 AM
by iffi
Why we need FDA/CE or any other certifications to use it for medical purposes in a hospital?
May 29, 2017 08:41 PM
by RadiAnt
For legal reasons in many countries some kind of certification is required for the dicom software to be used as a radiology reporting station.
Apr 24, 2019 01:53 PM
by aliec
Any news about cetification?
Apr 26, 2019 01:55 PM
by RadiAnt
Nothing specific to share at this moment...
Jun 5, 2019 07:46 PM
by bbgg
Is Radiant viewer FDA approved yet?
Jun 7, 2019 07:14 AM
by RadiAnt
Regarding FDA approval, there is no time-frame to share at this moment.
Feb 9, 2020 09:39 AM
by Staffnsnake
Any FDA/CE updates?
Feb 11, 2020 11:45 PM
by RadiAnt
No updates at this time.
Jun 11, 2020 10:48 AM
by KTY
Hi, apart from the legal aspects of FDA approval, technical wise, is there anything that makes Radiant not comparable to FDA/CE IIa marked software like Osirix MD, Mirada etc? My interest is in measurments eg SUVmax etc.


Jun 13, 2020 11:04 AM
by RadiAnt
Before each public version of RadiAnt is released, it is thoroughly tested and validated. In the process of validation the results are compared with what you can get using CE/FDA certified software.

I can't recall any reports of miscalculations since RadiAnt was made public 10 years ago. And it has been used by thousands of users who would certainly spot any inconsistencies.
Jun 13, 2020 06:33 PM
by Tommy
I'd like to add that RadiAnt is even better than other software who have a FDA/CE approval...
Jan 3, 2022 08:15 PM
by MRIGuy
You cannot legally use it in the USA for reading human images. Full stop. It's not an FDA approved product, same as you cannot use an x-ray machine that you brought over from some other country. If you are an aircraft mechanic, you cannot put non-FAA certified spark plugs in the airplane.

It does not matter if it seems OK to you, you may be correct the it works fine, but it's not approved. If you are in litigation and the opposing attorney gets hold of this he or she will make a big deal of it, and your insurance compnay will also not think highly of the practice.
Jan 4, 2022 08:27 AM
by @MRIGuy
Can a surgeon use the software to look at images that have previously been reported by a radiologist using a FDA approved software?
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