The following data is part of a premarket notification filed by Medtronic Navigation, Inc. (littleton) with the FDA for O-arm Imaging System.
| Device ID | K092564 |
| 510k Number | K092564 |
| Device Name: | O-ARM IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | MEDTRONIC NAVIGATION, INC. (LITTLETON) 300 FOSTER STREET Littleton, MA 01460 |
| Contact | Seth Kuzdzal |
| Correspondent | Seth Kuzdzal MEDTRONIC NAVIGATION, INC. (LITTLETON) 300 FOSTER STREET Littleton, MA 01460 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2010-06-17 |
| Summary: | summary |