FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
K Number: K133875
·
Decision Jan 17, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
3
Review Days
28
Basic Information
- Device Name
- THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
- K Number
- K133875
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORTHO KINEMATICS, INC.
- Date Received
- December 20, 2013
- Decision Date
- January 17, 2014
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by ORTHO KINEMATICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K130743 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL | Aug 6, 2013 | Substantially Equivalent |
| K112109 | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE | Dec 22, 2011 | Substantially Equivalent |