The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for O-arm O2 Imaging System.
| Device ID | K200074 |
| 510k Number | K200074 |
| Device Name: | O-arm O2 Imaging System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Medtronic Inc. 300 Foster St. Littleton, MA 01460 |
| Contact | Dean Honkonen |
| Correspondent | Dean Honkonen Medtronic Inc. 300 Foster St. 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 | 2020-01-14 |
| Decision Date | 2020-04-24 |