The following data is part of a premarket notification filed by Mri Division, Beijing Wandong Medical Technology Co., Ltd. with the FDA for I_space 1.5t Superconducting Magnetic Resonance Imaging System.
| Device ID | K192650 |
| 510k Number | K192650 |
| Device Name: | I_Space 1.5T Superconducting Magnetic Resonance Imaging System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI Division, Beijing Wandong Medical Technology Co., Ltd. No.7 Sanjianfang Nanli, Chaoyang District Beijing, CN 100024 |
| Contact | Zhou Lu |
| Correspondent | Zhou Lu MRI Division, Beijing Wandong Medical Technology Co., Ltd. No.7 Sanjianfang Nanli, 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 | 2019-09-24 |
| Decision Date | 2021-01-29 |