The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Magnifico Open, Magnifico Msk.
| Device ID | K212419 |
| 510k Number | K212419 |
| Device Name: | Magnifico Open, Magnifico MSK |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Esaote S.p.A. Via Enrico Melen 77 Genoa, IT 16152 |
| Contact | Alberto Carcagni |
| Correspondent | Alberto Carcagni Esaote S.p.A. Via Enrico Melen 77 Genoa, IT 16152 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304454744 | K212419 | 000 |
| 08056304454737 | K212419 | 000 |