The following data is part of a premarket notification filed by Visible Patient, Sas with the FDA for Visible Patient Suite.
| Device ID | K212896 |
| 510k Number | K212896 |
| Device Name: | Visible Patient Suite |
| Classification | System, Image Processing, Radiological |
| Applicant | Visible Patient, SAS 8 Rue Gustave Adolphe HIRN Strasbourg, FR 67000 |
| Contact | Emeline Degivry |
| Correspondent | John J Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2021-11-05 |