THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE


Device Classification Name

system, image processing, radiological

510(k) Number K112109
Device Name THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
Applicant
ORTHO KINEMATICS, INC.
555 13th street nw
washington, 
DC 
20005 -3096

Applicant Contact john j smith
Correspondent
ORTHO KINEMATICS, INC.
555 13th street nw
washington, 
DC 
20005 -3096

Correspodent Contact john j smith
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/22/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No