The following data is part of a premarket notification filed by Magnevu with the FDA for Orthovu-1000.
| Device ID | K981898 |
| 510k Number | K981898 |
| Device Name: | ORTHOVU-1000 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MAGNEVU 2225 FARADAY AVE. SUITE F Carlsbad, CA 92008 |
| Contact | Bob Rose |
| Correspondent | Bob Rose MAGNEVU 2225 FARADAY AVE. SUITE F Carlsbad, CA 92008 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-08-03 |
| Summary: | summary |