510(k) K081656 ยท LLZ System, Image Processing, Radiological
VISUALASE THERMAL THERAPY SYSTEM
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Sep 10, 2008 |
| Received | Jun 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2018 | Medtronic Navigation, Inc. Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.