The following data is part of a premarket notification filed by Breakaway Imaging, Llc with the FDA for O-arm Imaging System.
| Device ID | K060344 |
| 510k Number | K060344 |
| 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 | Rick Grant |
| Correspondent | Rick Grant BREAKAWAY IMAGING, LLC 300 FOSTER STREET Littleton, MA 01460 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-10 |
| Decision Date | 2006-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885074546180 | K060344 | 000 |
| 20643169803002 | K060344 | 000 |
| 20643169868131 | K060344 | 000 |