# K240094: LumiNE US; Lumi

- Pathway: 510(k) (Traditional)
- Applicant: Augmedit B.V.
- Decided: Sep 10, 2024 after 242 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213215: VSI HoloMedicine, Apoqlar GmbH (2022) Summary page 6.

## Indications for use
The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. The LumiNE US software is intended for use by a (neuro)surgeon, (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization in preparation of surgery, and not for diagnostic use. Therefore, segmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions. LumiNE US can only be used for contrast-enhanced T1 MR scans (semi-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation). The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3) and a maximal diameter in any direction of 75 mm (3.0 inch).

Source page: https://510kreport.com/device/K240094
Methodology: https://510kreport.com/methodology