The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Modification To Superopen 0.23t, Model Nam-p023a.
| Device ID | K062860 |
| 510k Number | K062860 |
| Device Name: | MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Contact | Tian Yanfang |
| Correspondent | Tian Yanfang NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-10-27 |
| Summary: | summary |