TOUCHPACS SUITE


Device Classification Name

system, image processing, radiological

510(k) Number K112008
Device Name TOUCHPACS SUITE
Applicant
TOUCH MEDICAL SOLUTIONS INC.
3455 university pkwy
winston-salem, 
NC 
27106 -4109

Applicant Contact james owen
Correspondent
TOUCH MEDICAL SOLUTIONS INC.
3455 university pkwy
winston-salem, 
NC 
27106 -4109

Correspodent Contact james owen
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/13/2011
Decision Date 01/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No