STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE


Device Classification Name

system, image processing, radiological

510(k) Number K081512
Device Name STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
Applicant
MEDTRONIC NAVIGATION, INC.
3025 perry street
denver, 
CO 
80212

Applicant Contact kevin morningstar
Correspondent
MEDTRONIC NAVIGATION, INC.
3025 perry street
denver, 
CO 
80212

Correspodent Contact kevin morningstar
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/30/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No