The following data is part of a premarket notification filed by Liaoning Kampo Medical System Co., Ltd. with the FDA for Supernova C5 Mri System.
| Device ID | K131737 |
| 510k Number | K131737 |
| Device Name: | SUPERNOVA C5 MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | LIAONING KAMPO MEDICAL SYSTEM CO., LTD. NO. 9, YAODU STREET, BENXI ECONOMIC DEVELOPMENT AREA Benxi, Liaoning, CN 117004 |
| Contact | Shao Kai |
| Correspondent | Shao Kai LIAONING KAMPO MEDICAL SYSTEM CO., LTD. NO. 9, YAODU STREET, BENXI ECONOMIC DEVELOPMENT AREA Benxi, Liaoning, CN 117004 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-13 |
| Decision Date | 2014-10-23 |
| Summary: | summary |