510(k) K130443 ยท OAS X-Ray, Tomography, Computed, Dental
I-MAX TOUCH 3D
| Applicant | Owandy, Ormond Beach FL, US |
| Decision | Substantially Equivalent, Jun 14, 2013 |
| Received | Feb 21, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K130443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Villa Radiology Systems LLC Owandy Radiology I -MAX Touch 3D X-ray Terminated |
OAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.