The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Brivo Mr355, Optima Mr360.
| Device ID | K123417 |
| 510k Number | K123417 |
| Device Name: | BRIVO MR355, OPTIMA MR360 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO.2, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE 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.ZONE Beijing, CN 100176 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118996 | K123417 | 000 |
| 00840682118958 | K123417 | 000 |