The following data is part of a premarket notification filed by Spectronic Medical Ab with the FDA for Mri Planner.
| Device ID | K211841 |
| 510k Number | K211841 |
| Device Name: | MRI Planner |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Spectronic Medical AB Karbingatan 36 Helsingborg, SE 25467 |
| Contact | Per Bruhn |
| Correspondent | Per Bruhn Spectronic Medical AB Karbingatan 36 Helsingborg, SE 25467 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-14 |
| Decision Date | 2022-08-25 |