FDA-cleared K240793

MSKai

MSKai

Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...

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