The following data is part of a premarket notification filed by Esaote S.p.a with the FDA for G-scan Brio.
| Device ID | K180592 |
| 510k Number | K180592 |
| Device Name: | G-scan Brio |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Esaote S.p.A Via Enrico Melen 77 Genova, IT 16152 |
| Contact | Massimo Polignano |
| Correspondent | Allison Scott Navigant Consulting, Inc 9100 Keystone Crossing Suite 500 Indianapolis, IN 46240 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-03-30 |
| Summary: | summary |