O-Scan
System, Nuclear Magnetic Resonance Imaging
Esaote S.p.A
The following data is part of a premarket notification filed by Esaote S.p.a with the FDA for O-scan.
Pre-market Notification Details
| Device ID | K183685 |
| 510k Number | K183685 |
| Device Name: | O-Scan |
| 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 | 2018-12-28 |
| Decision Date | 2019-01-22 |
| Summary: | summary |
Trademark Results [O-Scan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O-SCAN 88615661 not registered Live/Pending |
Premier Biotech 2019-09-13 |
 O-SCAN 85020283 3873577 Live/Registered |
Esaote, S.p.A. 2010-04-22 |
 O-SCAN 75828339 2678545 Dead/Cancelled |
OPINIONLAB, INC. 1999-10-21 |
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