The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for S-scan.
| Device ID | K161238 |
| 510k Number | K161238 |
| Device Name: | S-scan |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Esaote S.p.A. Via Siffredi 58 Genovo, IT 16153 |
| Contact | Donatella Ragghianti |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() S-SCAN 79147952 4718603 Live/Registered |
Stjernfjädrar AB 2014-04-16 |