510(k) K071308 ยท JAK System, X-Ray, Tomography, Computed
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
| Applicant | Neusoft Medical Systems Co., Ltd., Shenyang, CN |
| Decision | Substantially Equivalent, Aug 16, 2007 |
| Received | May 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2013 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system.
NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section im 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 |
| Jan 4, 2011 | Philips And Neusoft Medical Systems Co., Ltd. The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321.
Labeling on the device reads in part: "***Neusoft NeuViz Dual Terminated |
JAK | None listed |
| Aug 19, 2010 | Neuisys, LLC NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321.
Intended to produce cross-section images of head and body by
computer reconstruction of X-ray t Terminated |
JAK | None listed |
| Jan 26, 2009 | Philips Medical Systems North America Co. Phillips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).
Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions acco Terminated |
JAA | None listed |
| Sep 17, 2008 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz Dual series computed Tomography Scanner System, X-Ray System
The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and fun Terminated |
JAK | None listed |
| Sep 17, 2008 | Philips And Neusoft Medical Systems Co., Ltd. NeuViz Dual series computed Tomography Scanner System, X-Ray System Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.