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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