The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Magnaview Mobile Mri Version 110 Fhm.
| Device ID | K891543 |
| 510k Number | K891543 |
| Device Name: | MAGNAVIEW MOBILE MRI VERSION 110 FHM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Gerry Buss |
| Correspondent | Gerry Buss INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-06-23 |