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FDA-cleared K190764

SurgicalAR

MEDIVIS, Inc.

Authorized purpose: SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2019-05-13