Jump to content

Ocel

Members
  • Content Count

    3
  • Joined

  • Last visited

  1. Ocel

    FDA Legality Question

    Thank you so much Dr. Mike, and thank you for creating this community. I learned about it through an ACERT conference for radiology and have been on here ever since.
  2. Ocel

    FDA Legality Question

    That's what I am a little confused about. The FDA refers to the software itself as a type II medical device. It seems that one must use an FDA approved software if *services are going to be rendered to a Doctor or facility. It seems that Doctors themselves can use any software they want to create these prints.
  3. Hello, I'm hoping to find some answers to questions regarding the legalities of selling 3D rendering/printing services for local clinics. I have worked in Radiology as an X-Ray tech for 13 years as well as for my local Diagnostic Imaging Program as an adjunct instructor for 7 years. I am currently assessing the market for 3D modeling/printing services to clinics and hospitals. I have read the information from the FDA including the slides you have posted. If you don't mind I was hoping to ask you if you know of any clarification regarding the following: If a 3rd party company were selling 3D rendering/printing services of patient specific anatomy using imaging studies (CT,MRI) stated that the models were "not for diagnostic use" would that still require said 3rd party company to use FDA approved software to do so? If the models were used for diagnostic use would that fall under the liability of the MD or the 3rd party company or both?
×