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FDA-cleared K240465

O-arm O2 Imaging System

Medtronic Navigation, Inc

Authorized purpose: O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact reduction, and lower-dose Spine Smart Dose acquisition for labeled patients.

Modality
CBCT
Anatomy
Spine
Decision
2024-06-21