The following data is part of a premarket notification filed by Breakaway Imaging, Llc with the FDA for O-arm Imaging System.
| Device ID | K050996 |
| 510k Number | K050996 |
| Device Name: | O-ARM IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | BREAKAWAY IMAGING, LLC 300 FOSTER STREET Littleton, MA 01460 |
| Contact | Wolfgang Krull |
| Correspondent | Jeff Rongero UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-20 |
| Decision Date | 2005-05-05 |
| Summary: | summary |