510(k) K071636 ยท LLZ System, Image Processing, Radiological
CODIAGNOSTIX (R) 5.72
| Applicant | Ivs Solutions AG, Chemnitz, Saxony, DE |
| Decision | Substantially Equivalent, Aug 9, 2007 |
| Received | Jun 15, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill.
Imaging processing System Terminated |
LLZ | None listed |
| Mar 7, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, dental implant planning system.
Software Version 7.0 including updates 7.0.2 and 7.0.2.10 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.