The following data is part of a premarket notification filed by Neusoft Digital Medical Systems Co., Ltd. with the FDA for Superopen 0.35t, Model Nsm-p035.
| Device ID | K030918 |
| 510k Number | K030918 |
| Device Name: | SUPEROPEN 0.35T, MODEL NSM-P035 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Contact | Wang Zhiqiang |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-04-01 |
| Summary: | summary |