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FDA-cleared K183593

Lung Vision System

Body Vision Medical Ltd.

The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-04-18
FDA-cleared K163622

Lung Vision

BODY VISION MEDICAL LTD.

Authorized purpose: LungVision segments prior 3D CT and registers and overlays it with live fluoroscopic X-ray of the same anatomy to support catheter and device navigation during pulmonary procedures.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Pulmonary anatomy and catheter/device navigation targets
Decision
2017-05-11