510(k) K151383 ยท JAK System, X-Ray, Tomography, Computed
NeuViz 128 Multi-slice CT Scanner System
| Applicant | Neusoft Medical Systems Co., Ltd., Shenyang, CN |
| Decision | Substantially Equivalent, Nov 4, 2015 |
| Received | May 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2019 | NEUSOFT MEDICAL SYSTEMS IMP & EX NeuViz 128 Multi-slice CT Scanner System with
software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1
Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray
system featuring a Terminated |
JAK | None listed |
| Oct 22, 2018 | Neusoft Medical Systems Co., Ltd. NeuViz 128 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 tube and Terminated |
JAK | None listed |
| May 19, 2017 | Neusoft Medical Systems Co., Ltd. Neusoft NeuViz 128 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 Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.