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 |