The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Instrumentarium Mega4 Ht.
| Device ID | K925987 |
| 510k Number | K925987 |
| Device Name: | INSTRUMENTARIUM MEGA4 HT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | Richard E Halbach |
| Correspondent | Richard E Halbach INSTRUMENTARIUM IMAGING, INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-05-19 |