The following data is part of a premarket notification filed by Ningbo Xingaoyi Magnetism Co., Ltd. with the FDA for Oper Series Open Type Permanent-magnet Mri System, Model: Oper-0.3, -0.35, -0.4.
| Device ID | K092899 |
| 510k Number | K092899 |
| Device Name: | OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NINGBO XINGAOYI MAGNETISM CO., LTD. EAST TANJIALING RD. Yuyao, Zhejiang, CN 315400 |
| Contact | Jiang Mowen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2009-11-10 |
| Summary: | summary |