“Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA”
This guidance was issued April 2, 2001. Manufacturers are required to disclose to assemblers and others information related to X-ray systems to meet federal performance standard 1020.30G 21CFR.
This guidance document mentions software in a number of places and basically states that software programs associated with assembly, installation, adjustment and testing of X-ray systems must be provided upon request to assemblers and installers, and if this software is not sep1rated from internal software of the device then that is no exemption from providing the software needed to to meet the requirements of the regulation. If the software is bundled together it must be provided at cost and you can refer to the guidance document itself for the different types of software that are subject to these requirements.