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FDA-cleared K210719

Change Healthcare Anatomical AI

Change Healthcare Canada Company

Authorized purpose: Analyzes CT or MR pixel data to create anatomical descriptors for export and to help identify images, series, and studies.

Modality
CT/CTA; MRI
Anatomy
Abdomen; breast (MR only); calf; chest; elbow; foot; forearm; hand; head; arm; knee; neck; pelvis; shoulder; cervical spine; thoracic spine; lumbar spine; thigh
Decision
2021-07-20