Duns Number:078684808
Device Description: LungPoint VBN Software is software installed on a desktop computer used to plan procedures 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.
Catalog Number
30005
Brand Name
LungPoint VBN System, V3.2
Version/Model Number
30005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
bb61db56-74ca-45e1-a440-f39abf44ded8
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
June 27, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |