The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Mr Max System.
| Device ID | K895794 |
| 510k Number | K895794 |
| Device Name: | GE MR MAX SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-28 |
| Decision Date | 1989-11-17 |