The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for O-scan Mr System.
| Device ID | K092469 |
| 510k Number | K092469 |
| Device Name: | O-SCAN MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott ESAOTE S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-11 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304452535 | K092469 | 000 |
| 08056304452528 | K092469 | 000 |
| 08056304452511 | K092469 | 000 |
| 08056304455741 | K092469 | 000 |