LungPoint VBN System, V3.2 30005

GUDID 00856571007173

LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.

BRONCUS MEDICAL INC.

Virtual bronchoscopic navigation PACS software
Primary Device ID00856571007173
NIH Device Record Keybb61db56-74ca-45e1-a440-f39abf44ded8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungPoint VBN System, V3.2
Version Model Number30005
Catalog Number30005
Company DUNS078684808
Company NameBRONCUS MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-428-1600
EmailCustomerSupport@Broncus.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007173 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-23
Device Publish Date2017-06-27

Devices Manufactured by BRONCUS MEDICAL INC.

00856571007296 - Archimedes Access Kit2021-10-12 A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
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00856571007036 - Archimedes System2019-05-23 Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedu
00856571007104 - Archimedes Planning System2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
00856571007128 - LungPoint Planning System, v3.22019-05-23 LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
00856571007173 - LungPoint VBN System, V3.22019-05-23LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.
00856571007173 - LungPoint VBN System, V3.22019-05-23 LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung.
00856571007227 - Archimedes Access Key2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
00856571007258 - Archimedes Access Key, 10-pack2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
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