3-D IMAGING WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K081093
Device Name 3-D IMAGING WORKSTATION
Applicant
EIGEN LLC
13366 grass valley ave.
grass valley, 
CA 
95945

Applicant Contact mark a hoffman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/17/2008
Decision Date 05/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No