510(k) K033316 ยท JAI Couch, Radiation Therapy, Powered
TABLE TILT DEVICE
| Applicant | Brainlab AG, Heimstetten, DE |
| Decision | Substantially Equivalent, May 14, 2004 |
| Received | Oct 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2006 | Brainlab AG ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; Terminated |
JAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.