Do we have any validation Report for DCMTK Lib?

[Akshaybar Singh]

Dear DCMTK Member,

I am going to use DCMTK Lib in one of the functionality in PACS. The owner of PACS is asking about any validation report available for open source DCMTK Lib.
Please help on these if it is available, let me know any web link from where i can download or what could be satisfactory answer for the same.

Thanks in advance.

Thanks & Regards
Akshay

[Michael Onken]

Hi,

I am not aware of any validation report of any type.

Also I am not sure what kind of validation you are referring to, e.g. DCMTK as a software under the medical device directive or with FDA label? We know various companies that use DCMTK in their medical products but I don't know how they did their validation.

Best regards,
Michael

[Akshaybar Singh]

Thank you so much Michael Onken for your reply.

As you mentioned this line [DCMTK as a software under the medical device directive or with FDA label?], yes, i wanted know DCMTK is approved by FDA or any medical device directive association.

Please do let me know if any Medical Directive association approved DCMTK open source to be use medical device related software.

Thanks & Regards
Akshay

[Michael Onken]

Hi,

some vendors definitely have such an approval with DCMTK as part of their system but I dont know how they did it and we (DCMTK team) do not have any validation reports.

Best,
Michael