The following data is part of a premarket notification filed by Jiangsu Magspin Instrument Co.,ltd with the FDA for Magnetic Reasonance Imaging System.
| Device ID | K151074 |
| 510k Number | K151074 |
| Device Name: | Magnetic Reasonance Imaging System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | JIANGSU MAGSPIN INSTRUMENT CO.,LTD BUILDING 9, NO.299, YUYANG ROAD Kunshan, CN 215300 |
| Contact | Leo Li |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd, Baiyun District Guangzhou, CN 510420 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2015-12-22 |
| Summary: | summary |