The following data is part of a premarket notification filed by Wandong Medical with the FDA for I Open 0.36 T-magnetic Resonance Imaging System.
| Device ID | K042948 |
| 510k Number | K042948 |
| Device Name: | I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | WANDONG MEDICAL NO. 7 SANJIANFANG NANLI CHAOYANG DISTRICT Beijing, CN 100024 |
| Contact | Wang Weimin |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-26 |
| Decision Date | 2004-11-03 |