Device Dossier
MRI system, application program software
Device Dossier for MRI system, application program software (MRI system, application program software, Class IIa, sponsor Columbo). ARTG record, intended…
- GMDN category: MRI system, application program software
Intended purpose
The purpose of the device is to assist in reading MR lumbar spine images and providing information on detected pathologies and abnormalities, as well as reducing the time to write the report. The results are reviewed and confirmed by a radiologist. The software performs: automatic segmentation of vertebrae, disks, herniated part of the disc (without sequestered part), dural sac, ligamentum flavum, nerve roots; measurements of intervertebral angles, L1S1 lordotic angle, vertebral height, disc height, herniation size, cross-sectional area of the dural sac; diagnosis of herniation (without fully sequestered), bulging, central spinal stenosis, compression of nerve roots, spondylolisthesis and pseudolisthesis, presence of hypo- or hyperlordosis / straight or accentuated spine.