The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for 1.5t Infinity Twinspeed Mr System.
| Device ID | K012200 |
| 510k Number | K012200 |
| Device Name: | 1.5T INFINITY TWINSPEED MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-08-03 |
| Summary: | summary |