The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Instrumentarium Mega4.
| Device ID | K915552 | 
| 510k Number | K915552 | 
| Device Name: | INSTRUMENTARIUM MEGA4 | 
| Classification | System, Nuclear Magnetic Resonance Imaging | 
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 | 
| Contact | Richard E Halbach | 
| Correspondent | Richard E Halbach 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 | 1991-12-11 | 
| Decision Date | 1992-02-27 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() INSTRUMENTARIUM MEGA4  74152266  1725173 Dead/Cancelled  | 
        INSTRUMENTARIUM OY  1991-03-25  |