OMNI-VUE SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K073062
Device Name OMNI-VUE SYSTEM
Applicant
GENESIS DIGITAL IMAGING, INC.
1600 manchester way
corinth, 
TX 
76210

Applicant Contact carl alletto
Correspondent
GENESIS DIGITAL IMAGING, INC.
1600 manchester way
corinth, 
TX 
76210

Correspodent Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 10/30/2007
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No