The following data is part of a premarket notification filed by Perspectum Diagnostics Ltd with the FDA for Livermultiscan.
Device ID | K172685 |
510k Number | K172685 |
Device Name: | LiverMultiScan |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Perspectum Diagnostics Ltd 23-38 Hythe Bridge Street Oxford, GB Ox1 2et |
Contact | Jaco Jacobs |
Correspondent | Jaco Jacobs Perspectum Diagnostics Ltd 23-38 Hythe Bridge Street Oxford, GB Ox1 2et |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-06 |
Decision Date | 2017-11-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B554LMS2100 | K172685 | 000 |
B554LMS2000 | K172685 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LIVERMULTISCAN 88601547 not registered Live/Pending |
Perspectum Diagnostics Ltd 2019-09-02 |