510(k) K964712 ยท KPS System, Tomography, Computed, Emission
PRISM XPVT SYSTEM (210823)
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 21, 1997 |
| Received | Nov 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964712
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Feb 10, 2012 | Philips Medical Systems (Cleveland) Inc Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare.
Used to do nuclear medicine diagnostic imaging of various body organs. Terminated |
KPS | None listed |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | None listed |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | None listed |
| Sep 19, 2008 | Philips Medical Systems (Cleveland) Inc Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 Terminated |
KPS | None listed |
| Nov 6, 2003 | Philips Medical Systems (Cleveland) Inc Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.