LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K112051
Device Name LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
Applicant
BRONCUS TECHNOLOGIES, INC.
1400n shoreline blvd.
bldg. a, suite i
mountain view, 
CA 
94043

Applicant Contact mahtab fatemi
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/18/2011
Decision Date 10/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No