510(k) K133875 ยท LLZ System, Image Processing, Radiological
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
| Applicant | Ortho Kinematics, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Dec 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2018 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA), 2.3.250.
Product System, image processing, radiological Open, Classified |
LLZ | None listed |
| Mar 2, 2017 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254.
Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files. Open, Classified |
LLZ | None listed |
| Jan 11, 2017 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA) Version 2.3.252.
VMA software is a quantitative imaging software application intended to be used to process digital image files. Open, Classified |
LLZ | None listed |
| Aug 12, 2016 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232.
Product Usage:
VMA software is a quantitative imaging software application intended to be used to process digital image files Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.