Looking for a (validated) DICOM tag editor - DICOM

This is a discussion on Looking for a (validated) DICOM tag editor - DICOM ; Greetings! I have searched this group, but did not find much on this topic, so I'm asking. Can anybody recommend an editor for DICOM tags? It is important that it has been validated according to 21 CFR Part 11. Personally, ...

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Thread: Looking for a (validated) DICOM tag editor

  1. Looking for a (validated) DICOM tag editor

    Greetings!

    I have searched this group, but did not find much on this topic, so
    I'm asking.

    Can anybody recommend an editor for DICOM tags? It is important that
    it has been validated according to 21 CFR Part 11.

    Personally, I am also interested in other editors, as long as they are
    free or cheap. Usually I use dcmodify from the Offis DCMTK, but
    something with a GUI would be fine to have. Anonymizing features would
    also be nice. The OS does not really matter.

    Thanks,

    Alex


  2. Re: Looking for a (validated) DICOM tag editor

    Hello Alex,

    PowerDicom is an editor/viewer/converter/.. for DICOM files on the
    Windows platform.
    PowerDicom can be used both interactively (intuitive GUI) and automated
    (automation/COM-server, e.g. for anonymizing).

    Detailed information and a trial edition are available on
    http://www.dicom-solutions.com/powerdicom.shtm.

    Greetings
    Marianne


  3. Re: Looking for a (validated) DICOM tag editor


    Alex Schuster wrote:

    > Can anybody recommend an editor for DICOM tags? It is important that
    > it has been validated according to 21 CFR Part 11.
    >


    What aspect of 21 CFR Part 11 are you looking for the tool to include?
    Typically when this requirement is cited, it is user security, logging
    of changes, and electronic signature requirement --ie changes only
    allowed to validated/priviledge users, all changes to metadata logged,
    and user signing off on what they changed and reason for change.
    However, this type of functionality extends beyond a mere dicom edit
    capability is really more the type of requirement that you would see
    where an editor is integrated into a controlled repository with these
    functions.

    Another possibility t is the 21 CFR P11 requirement for a documented
    system engineering, software development, and software maintenance
    process for software tools used in a 21 CFR P11 controlled business
    process (e.g. imaging tools used in clinical trials for drug
    development). This requirement is typically problematic, or at least
    more work than a lot of people want to go through, when one wants to
    incorporate open source software as a tool in one of these processes.
    By their nature, open source software is extended and maintained by a
    variety of personnel in loose cooperative network rather than in
    tightly controlled and change reviewed manner. To use open source
    software, a company or organization has to show their process for
    controlling the content of software by documenting and testing the
    baseline functionality, and then either maintaining the code base in
    their own update process, or establishing a systematic review process
    for all updates accepted from the open source repository.

    On the other hand, the good manufacturing processess required for FDA
    510k registration are essentially the same as the software engineering
    processes required for 21 CFR P11. Mainly it is paperwork to
    prove/establish this is in fact the case. Bottomline, if there is a
    DICOM edit capability in a commercially available imaging product which
    is subject to FDA oversight under a 510K, you're most of the way there.


    In addition to the DICOM edit capabilities of the DCMTK from OFFIS, I
    am enamoured with a couple different edit capabilities in the GE
    Centricity RA600 product (formerly Applicare Radworks). There is a
    manual edit mode in their QC Module. This is particularly nice because,
    edits applied at the Patient, Study or Series level propagate down into
    all the instances below the parent entity being editted. The software
    also has scripting capability which is applied on receipt via DICOM
    network store. Scripts are written in Javascript and configured such
    that they execute when an association from a specific AE/IP combination
    is received. You can excute conditional logic, including doing lookup
    of values in external databases. Calls within the script allow you to
    apply changes to DICOM tags which are then either applied or thrown
    away upon exist from the script: exit(true) applies, exit(false) rolls
    back. On the downside, the scripts do not have the capability to
    edit/modify the header below the "main sequence" of the image, so you
    cannot modify the contents of items in sequences.

    A couple other editor tools are included in the set of Jdicom utilities
    from Tianni, "EditDicomDir" and "EditDicomObject". These used to be
    openly available/open source but have been hard to locate (at least for
    me) since Agfa purchased Tianni. I've heard they're still floating
    around out there on various mirrors of old sites, but had to receive
    mine from a friend who had kept a copy on CD.


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