The following data is part of a premarket notification filed by Perspectum Diagnostics Ltd with the FDA for Livermultiscan (lmsv3).
| Device ID | K190017 |
| 510k Number | K190017 |
| Device Name: | LiverMultiScan (LMSv3) |
| 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 | 2019-01-03 |
| Decision Date | 2019-06-27 |