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 Mri System, Model Nam-p023a.
| Device ID | K082485 |
| 510k Number | K082485 |
| Device Name: | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, 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 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2008-09-09 |
| Summary: | summary |