510(k) K121792 ยท JAK System, X-Ray, Tomography, Computed
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
| Applicant | Neusoft Medical Systems Co., Ltd., Echo OR, US |
| Decision | Substantially Equivalent, Nov 16, 2012 |
| Received | Jun 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2018 | Neusoft Medical Systems Co., Ltd. NeuViz 64 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 |
| Aug 31, 2016 | Neusoft Medical Systems Co., Ltd. NeuViz 64 Multi-slice CT Scanner Systems Terminated |
JAK | None listed |
| Aug 31, 2016 | Neusoft Medical Systems Co., Ltd. NeuViz 128 Multi-slice CT Scanner System with
software version 1.0.7.4038+P06 or previous version Terminated |
JAK | None listed |
| Jun 16, 2015 | Neusoft Medical System Co Neusoft NeuViz 64 Multi-slice CT Scanner System Terminated |
JAK | None listed |
| May 2, 2015 | Neusoft Medical Systems Co., Ltd. NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.