The following data is part of a premarket notification filed by Mri Division,beijing Wandong Medical Technology Co.,ltd. with the FDA for I_ Field 1.5t Superconducting Magnetic Resonance Imaging System.
| Device ID | K221025 |
| 510k Number | K221025 |
| Device Name: | I_ Field 1.5T Superconducting Magnetic Resonance Imaging System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI Division,Beijing Wandong Medical Technology Co.,Ltd. No.38, Chaoyang Road, Chaoyang District Beijing, CN 100024 |
| Contact | Wang Huan |
| Correspondent | Wang Huan MRI Division,Beijing Wandong Medical Technology Co.,Ltd. No.38, Chaoyang Road, Chaoyang District Beijing, CN 100024 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-06 |
| Decision Date | 2022-07-01 |