510(k) K053610 ยท JAK System, X-Ray, Tomography, Computed
ABARIS
| Applicant | Traxtal Technologies, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Dec 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2011 | Philips Medical Systems North America Co. Phillips The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument.
The Tool Terminated |
JAK | None listed |
| May 19, 2011 | Philips Medical Systems North America Co. Phillips PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911.
Designed to be used only with the PercuNav" image guided intervention system. The Field Generator St Terminated |
JAK | None listed |
| Dec 14, 2010 | Philips Healthcare Inc. The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require ster Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.