510(k) K143586 ยท LLZ System, Image Processing, Radiological
FACT Medical Imaging Sysytem
| Applicant | Dexin Medical Imaging Technology Co., Ltd., Weinan Hign-Tech Zone, CN |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Dec 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143586
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.