FDA.reportPublic FDA data

LungVision System

Primary DI
07290017652085
Brand
LungVision System
Company
BODY VISION MEDICAL LTD
Model
Core
Catalog number
LV1055002
Device description
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. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
Published
2021-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017652085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017652085072900176520857290017652085

GMDN Terms#

Term, Definition table
TermDefinition
Virtual bronchoscopic navigation PACS softwareA software application intended to add specific image processing and/or analysis capabilities to a picture archiving and communication system (PACS) used for virtual bronchoscopic navigation (VBN). It is typically used by a bronchoscopist as a navigation system to help plan and provide guidance of a flexible bronchoscope to predefined target sites [also referred to as region of interest (ROI)] in the lung tissue of the tracheobronchial tree. It typically uses computed tomography (CT) scans in digital imaging and communications in medicine (DICOM) format. This software is typically installed in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600280073
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017652153LungVision ToolBridgeLV20550402021-10-20
07290017652160LungVision ToolBridgeLV20550412021-10-20
07290017652177LungVision ToolBridgeLV20550422021-10-20
07290017652184LungVision ToolBridgeLV20550432021-10-20
07290017652191LungVision SmartWireBridgeLV20550502021-10-13
07290017652139LungVision ToolBridgeLV20550302021-07-12
07290017652146LungVision ToolBridgeLV20550312021-07-12
07290017652108LungVision ToolBridgeLV20550112021-04-11
07290017652115LungVision ToolBridgeLV20550202021-07-12
07290017652122LungVision ToolBridgeLV20550212021-07-12
07290017652092LungVision ToolBridgeLV20550102021-04-13
07290017652061LungVision ToolBridgeLV20550042020-01-01
07290017652078LungVision ToolBridgeLV20550052020-01-01
07290017652047LungVision ToolBridgeLV20550032019-07-11
07290017652054LungVision ToolBridgeLV20550022019-07-11
07290017652030LungVision SystemCoreLV10550012019-05-29
07290017652016LungVision ToolBridgeLV20550002018-07-12
07290017652023LungVision ToolBridgeLV20550012018-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20