The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for G-scan Brio, S-scan.
| Device ID | K161973 |
| 510k Number | K161973 |
| Device Name: | G-scan Brio, S-scan |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Esaote S.p.A. Via Siffredi 58 Genova, IT 16153 |
| Contact | Maria Marzapane |
| Correspondent | Allison Scott Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304452719 | K161973 | 000 |