SyMRI
System, Nuclear Magnetic Resonance Imaging
SyntheticMR AB
The following data is part of a premarket notification filed by Syntheticmr Ab with the FDA for Symri.
Pre-market Notification Details
| Device ID | K162943 |
| 510k Number | K162943 |
| Device Name: | SyMRI |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SyntheticMR AB Storgatan 11 Linkoping, SE 582 23 |
| Contact | Maria Almesaker |
| Correspondent | Raymond Kelly Licensale Inc. 68 Southwoods Ter Southbury, CT 06488 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-21 |
| Decision Date | 2017-08-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340024700023 | K162943 | 000 |
Trademark Results [SyMRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMRI 85974094 4661808 Live/Registered |
Synthetic MR AB (publ) 2013-07-01 |
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