The following data is part of a premarket notification filed by Ortho Kinematics, Inc. with the FDA for The Kinegraph Vma Software, The Motion Normalizer Patient Handling And Data Collection Device.
| Device ID | K112109 |
| 510k Number | K112109 |
| Device Name: | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE |
| Classification | System, Image Processing, Radiological |
| Applicant | ORTHO KINEMATICS, INC. 555 13TH STREET NW Washington, DC 20005 -3096 |
| Contact | John J Smith |
| Correspondent | John J Smith ORTHO KINEMATICS, INC. 555 13TH STREET NW Washington, DC 20005 -3096 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-12-22 |
| Summary: | summary |