The following data is part of a premarket notification filed by Perspectum Diagnostics Ltd with the FDA for Mrcp+ V1.0.
| Device ID | K183133 |
| 510k Number | K183133 |
| Device Name: | MRCP+ V1.0 |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-01-09 |
| Summary: | summary |