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I've never worked on anything subject to medical regulation, but regarding open source tools, common open source licenses such as the MIT License [1], BSD Licen

• DrMeric 8mo ago
  > To follow up with some research I did on this: > > No free DICOM viewer on the market carries FDA clearance or CE marking. Not 3D Slicer [1], not Horos [2], not OHIF. Even RadiAnt — which is paid and arguably the most popular Windows viewer — explicitly states "our viewer is not a medical product" and has no FDA/CE certification or timeline for one [3]. Interestingly, RadiAnt is also a solo-developer operation (Medixant, Poznań) — so the indie medical imaging developer is not a new phenomenon. > > The only DICOM viewer with both FDA 510(k) and CE Class IIa is OsiriX MD — paid (~$69/mo), Mac-only. > > What's interesting is how the open-source ecosystem handles this. As @shoo noted, license disclaimers provide baseline liability protection. But beyond that, both 3D Slicer and OHIF have served as the foundation for FDA-cleared commercial products — Kitware built an FDA-cleared lung imaging tool on top of Slicer [4], and OHIF's GitHub explicitly notes it has "served as the basis for many FDA Cleared medical imaging viewers" [5]. > > So the pattern seems to be: the platform stays uncertified, companies build certified products on top of it. The certification barrier appears to be fundamentally an enterprise-level compliance investment (ISO 13485 QMS, 510(k) submission, post-market surveillance) — not a reflection of software quality. > > OrthoRay sits in the same regulatory space as every other free viewer. The difference is the intended audience — orthopedic surgeons doing preoperative planning, teaching, and research — not primary radiological diagnosis. > > What I'm more curious about is the performance side. I built OrthoRay's rendering pipeline in Rust/wgpu because I kept hitting walls with existing viewers when doing real-time 3D volume rendering and MPR reconstruction on large datasets. The bottleneck wasn't the UI — it was the engine. I think there's an underserved gap in academic and research workflows where real-time GPU-accelerated rendering matters — intraoperative planning, surgical simulation, 3D reconstruction from CT/MRI for teaching. > > @verdverm — from your position in the commercial space, do you see demand for this kind of native, GPU-first rendering performance? Or is the industry moving entirely toward cloud/server-side rendering and the local viewer is becoming irrelevant? > > [1] https://www.slicer.org/commercial-use.html https://www.slicer.org/commercial-use.html > [2] https://groups.google.com/g/horos-project/c/TksXEbIDDek https://groups.google.com/g/horos-project/c/TksXEbIDDek > [3] https://www.radiantviewer.com/dicom-viewer-forum/ce-certification/887/ https://www.radiantviewer.com/dicom-viewer-forum/ce-certific... > [4] https://www.kitware.com/kitware-supports-development-and-launch-of-fda-cleared-mr-image-processingsoftware-for-lung-ventilation-imaging/ https://www.kitware.com/kitware-supports-development-and-lau... > [5] https://github.com/OHIF/Viewers https://github.com/OHIF/Viewers