The following data is part of a premarket notification filed by Paramed Srl with the FDA for Mrj 3300.
| Device ID | K122034 |
| 510k Number | K122034 |
| Device Name: | MRJ 3300 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PARAMED SRL CORSO F.M. PERRONE 73R Genoa, IT 16152 |
| Contact | Luisella Debenedetti |
| Correspondent | Luisella Debenedetti PARAMED SRL CORSO F.M. PERRONE 73R Genoa, IT 16152 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2012-12-06 |
| Summary: | summary |