FDA.reportPublic FDA data

LungVision System

Primary DI
07290017652030
Brand
LungVision System
Company
BODY VISION MEDICAL LTD
Model
Core
Catalog number
LV1055001
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.
Published
2019-05-29
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
07290017652030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017652030072900176520307290017652030

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
07290017652085LungVision SystemCoreLV10550022021-04-13
07290017652092LungVision ToolBridgeLV20550102021-04-13
07290017652061LungVision ToolBridgeLV20550042020-01-01
07290017652078LungVision ToolBridgeLV20550052020-01-01
07290017652047LungVision ToolBridgeLV20550032019-07-11
07290017652054LungVision ToolBridgeLV20550022019-07-11
07290017652016LungVision ToolBridgeLV20550002018-07-12
07290017652023LungVision ToolBridgeLV20550012018-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03