The following data is part of a premarket notification filed by Xioao Mdt Technology Co Ltd with the FDA for Open Magnetic Resonance Imaging System, Model Mpf3000-iii.
| Device ID | K091669 |
| 510k Number | K091669 |
| Device Name: | OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | XIOAO MDT TECHNOLOGY CO LTD UNDERWRITERS LABORATORIES, INC 333 PFINGSTEN ROAD Northbrook, IL 60062 -2096 |
| Contact | Diana Hong |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-06-18 |
| Summary: | summary |