510(k) K083498 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MODEL MX 16 SLICE CT SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Philips Medical Systems (Cleveland) Inc MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array wi Terminated |
JAK | None listed |
| Oct 17, 2013 | Philips Medical Systems (Cleveland) Inc MX 16-Slice CT Scanner System.
Used as a whole-body computed tomography X-Ray system. Terminated |
JAK | None listed |
| Feb 28, 2013 | Philips Medical Systems (Cleveland) Inc Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. Terminated |
JAK | None listed |
| Sep 14, 2012 | Philips Medical Systems (Cleveland) Inc MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system. Terminated |
JAK | None listed |
| Apr 26, 2011 | Philips Medical Systems (Cleveland) Inc MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371.
The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system f Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.