510(k) K050996 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
O-ARM IMAGING SYSTEM
| Applicant | Breakaway Imaging, LLC, Littleton MA, US |
| Decision | Substantially Equivalent, May 5, 2005 |
| Received | Apr 20, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K050996
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2010 | Medtronic Navigation, Inc. O-Arm Imaging System
The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging. Terminated |
LLZ | None listed |
| Feb 4, 2009 | Medtronic Navigation, Inc Medtronic O-Arm Intraoperative Imaging System
Catalog Number: BI-700-00027 Terminated |
IZL | None listed |
| Sep 26, 2008 | Medtronic Navigation, Inc. BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System
Generating 2D and 3D images of human anatomy for surgical applications. Terminated |
JAA | None listed |
| Nov 27, 2007 | Medtronic Navigation, Inc Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460
(software version 3.0) Terminated |
JZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.