The following data is part of a premarket notification filed by Perspectum Ltd with the FDA for Livermultiscan.
Device ID | K202170 |
510k Number | K202170 |
Device Name: | LiverMultiScan |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Perspectum LTD Gemini One, 5520 John Smith Drive Oxford, GB Ox4 2ll |
Contact | Jaco Jacobs |
Correspondent | Jaco Jacobs Perspectum LTD Gemini One, 5520 John Smith Drive Oxford, GB Ox4 2ll |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-03 |
Decision Date | 2020-10-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() LIVERMULTISCAN 88601547 not registered Live/Pending |
Perspectum Diagnostics Ltd 2019-09-02 |