The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for G-scan Brio.
| Device ID | K133490 |
| 510k Number | K133490 |
| Device Name: | G-SCAN BRIO |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Contact | Allison S Cott |
| Correspondent | Allison S Cott ESAOTE S.P.A. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2013-12-30 |
| Summary: | summary |