LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.
Intended Use
Software interface and image segmentation system for pre-surgical planning tasks, intended for use by clinicians with clinical judgment. It provides 3D visualization from CT data for intraoperative display and consultation, adjunct to diagnostic interpretation but not for primary diagnosis.
Technology
LUMYS includes the Microsoft HoloLens 2 headset for mixed reality visualization, a broadcasting computer to transfer video from medical imaging devices, and a web browser interface for remote users. The software processes 3D volumetric CT data to generate stereoscopic images and supports image annotation and segmentation, facilitating collaborative pre-surgical planning and intraoperative consultation.
Performance
The device was developed and validated according to FDA and IEC standards, with usability testing showing it meets clinician needs. Optical testing confirmed suitability of visualization through the Microsoft HoloLens 2. Segmentation algorithm validation showed segmentation errors below 0.9 mm. Overall testing supports safety, effectiveness, and substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
7 months - 2
FDA Approval
5/2/2025
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