LiverMultiScan
System, Nuclear Magnetic Resonance Imaging
MIRADA MEDICAL LTD.
The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Livermultiscan.
Pre-market Notification Details
| Device ID | K143020 |
| 510k Number | K143020 |
| Device Name: | LiverMultiScan |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MIRADA MEDICAL LTD. OXFORD CENTRE FOR INNOVATION NEW ROAD Oxford, GB Ox1 1by |
| Contact | Gwilym Owen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-06-23 |
| Summary: | summary |
Trademark Results [LiverMultiScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIVERMULTISCAN 88601547 not registered Live/Pending |
Perspectum Diagnostics Ltd 2019-09-02 |
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