The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for O-arm O2 Imaging System.
| Device ID | K151000 |
| 510k Number | K151000 |
| Device Name: | O-Arm O2 Imaging System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | MEDTRONIC INC. 300 FOSTER STREET Littleton, MA 01460 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha MEDTRONIC INC. 300 FOSTER STREET Littleton, MA 01460 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-08-06 |
| Summary: | summary |