3VISEON/SURGERY


Device Classification Name

system, image processing, radiological

510(k) Number K072653
Device Name 3VISEON/SURGERY
Applicant
3MENSIO MEDICAL IMAGING BV
1600 manchester way
denton, 
TX 
76210

Applicant Contact carl thomas
Correspondent
3MENSIO MEDICAL IMAGING BV
1600 manchester way
denton, 
TX 
76210

Correspodent Contact carl thomas
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/20/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No