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
Primary Device ID07290017652030
NIH Device Record Key83ca6b2f-89cf-4586-8027-718d0526d54e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungVision System
Version Model NumberCore
Catalog NumberLV1055001
Company DUNS600280073
Company NameBODY VISION MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017652030 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-06
Device Publish Date2019-05-29

On-Brand Devices [LungVision System]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.