FDA-cleared K240094
LumiNE US; Lumi
Augmedit B.V.
Authorized purpose: LumiNE converts adult CT or contrast-enhanced T1 MR images into reviewed three-dimensional models and displays two- and three-dimensional images in a browser or Microsoft HoloLens 2 for preoperative planning, not diagnosis.
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain
- Decision
- 2024-09-10