510(k) K162002 ยท IYE Accelerator, Linear, Medical
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
| Applicant | Zdi, Solutions, LLC, Knoxville TN, US |
| Decision | Substantially Equivalent, Nov 1, 2016 |
| Received | Jul 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162002
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.