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FDA-cleared K240943

LungVision

BodyVision Medical Ltd.

Authorized purpose: The LungVision System enables users to segment previously acquired 3D CT datasets and overlay and register those segmented datasets with fluoroscopic live X-ray images of the same anatomy to support catheter or device navigation during pulmonary procedures.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Lungs; bronchial airways; pulmonary procedures
Decision
2024-10-01