The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Brivo Mr355.
| Device ID | K120778 |
| 510k Number | K120778 |
| Device Name: | BRIVO MR355 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.2, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.AREA Beijing, CN 100176 |
| Contact | Ruoqian Liu |
| Correspondent | Ruoqian Liu GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.2, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.AREA Beijing, CN 100176 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-03-14 |
| Decision Date | 2012-03-27 |
| Summary: | summary |