510(k) K171198 ยท JAK System, X-Ray, Tomography, Computed
NeuViz 16 Essence Multi-slice CT Scanner System
| Applicant | Neusoft Medical Systems Co., Ltd., Shenyang, CN |
| Decision | Substantially Equivalent, Dec 7, 2017 |
| Received | Apr 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171198
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2018 | Neusoft Medical Systems Co., Ltd. NeuViz 16 Essence Multi-slice CT Scanner System
Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray t Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.