LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM

System, Image Processing, Radiological

BRONCUS TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Lungpoint Virtual Bronchoscopic Navigation Vbn System.

Pre-market Notification Details

Device IDK091160
510k NumberK091160
Device Name:LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant BRONCUS TECHNOLOGIES, INC. 1400 N. SHORELINE BLVD. BLDG A SUITE 8 Mountain Veiw,  CA  94043
ContactMahtab Fatemi
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-04-21
Decision Date2009-05-05
Summary:summary

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.