LungVision System LV1055001

GUDID 07290017652030

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

BODY VISION MEDICAL LTD

Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software Virtual bronchoscopic navigation PACS software

• Primary Device ID: 07290017652030
• NIH Device Record Key: 83ca6b2f-89cf-4586-8027-718d0526d54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungVision System
• Version Model Number: Core
• Catalog Number: LV1055001
• Company DUNS: 600280073
• Company Name: BODY VISION MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017652030 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-06
• Device Publish Date: 2019-05-29

On-Brand Devices [LungVision System]

• 07290017652030: The LungVision System is designed to enable users to segment previously acquired 3D CT data sets
• 07290017652085: The LungVision System is designed to enable users to segment previously acquired 3D CT data sets