510(k) K092742 ยท JAK System, X-Ray, Tomography, Computed
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
| Applicant | Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, CN |
| Decision | Substantially Equivalent, Sep 22, 2009 |
| Received | Sep 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2016 | Philips and Neusoft Medical Systems Co., Ltd. NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501
a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to Terminated |
JAK | None listed |
| Apr 23, 2013 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system.
The NeuViz 16 CT Scanner System can be used as a whole body c Terminated |
JAK | None listed |
| Dec 4, 2012 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321
The NeuViz 16 CT Scanner System can be used as a whole body compute Terminated |
JAK | None listed |
| Jul 26, 2012 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501.
The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM* Terminated |
JAK | None listed |
| May 23, 2011 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501.
The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM* Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.