510(k) K060344 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
O-ARM IMAGING SYSTEM
| Applicant | Breakaway Imaging, LLC, Littleton MA, US |
| Decision | Substantially Equivalent, Mar 29, 2006 |
| Received | Feb 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060344
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.