The following data is part of a premarket notification filed by Perspectum Ltd. with the FDA for Coverscan V1.
| Device ID | K212565 |
| 510k Number | K212565 |
| Device Name: | CoverScan V1 |
| Classification | System, Image Processing, Radiological |
| Applicant | Perspectum Ltd. 5520 John Smith Drive Oxford, GB OX4 2LL |
| Contact | Ioan Wigley |
| Correspondent | Ioan Wigley Perspectum Ltd. 5520 John Smith Drive Oxford, GB OX4 2LL |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2022-05-19 |