FDA-cleared K240793
MSKai
MSKai
Authorized purpose: Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is not a diagnostic device.
- Modality
- MRI
- Anatomy
- Lumbar spine, including vertebral bodies L1-S1, intervertebral discs, cord canal, dural sac, nerve roots, and posterior arch.
- Decision
- 2024-12-16