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
|
|
Correspondent Contact |
JOHN J SMITH |
Regulation Number | 892.2050
|
Classification Product Code |
|
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
|
|
|