510(k) K091195 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, May 27, 2009 |
| Received | Apr 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16
Models: 728131 Open, Classified |
JAK | None listed |
| Apr 20, 2016 | Philips Medical Systems (Cleveland) Inc MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. Terminated |
JAK | None listed |
| Apr 20, 2016 | Philips Medical Systems (Cleveland) Inc MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| 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 |
| 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.