The role of File Set Creator shall be used by Application Entities which generate a File Set under the STD-US class of Application Profiles. Typical entities using this role would include ultrasound imaging equipment, workstations, and archive systems which generate a patient record for transfer. File Set Creators shall be able to generate the DICOMDIR directory file, single and/or multi frame Ultrasound Information Object files, and depending on the subclass, region specific calibration in the defined Transfer Syntaxes.

An FSC shall offer the ability to either finalize the disc at the completion of the most recent write session (no additional information can be subsequently added to the disc) or to allow multi-session (additional information may be subsequently added to the disc) or to allow packet-writing, if supported by the media and file system specified in the profile.