510(k) K032243 ยท JAK System, X-Ray, Tomography, Computed
MINICAT DENTOCAT
| Applicant | Xoran Technologies, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Oct 2, 2003 |
| Received | Jul 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2009 | Xoran Technologies, Inc. Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI.
Cone beam CT for sinus, temporal bones, and maxillofacial imaging. Terminated |
JAK | None listed |
| Feb 7, 2008 | Xoran Technologies, Inc. Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI Terminated |
JAK | None listed |
| Nov 27, 2007 | Xoran Technologies, Inc. Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.