CT-GUIDE NEEDLE GUIDANCE SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K110812
Device Name CT-GUIDE NEEDLE GUIDANCE SYSTEM
Applicant
ACTIVIEWS LTD
555 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact john j smith
Correspondent
ACTIVIEWS LTD
555 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact john j smith
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 03/23/2011
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Clinical Trials NCT01183182
Reviewed by Third Party No

Combination Product

No