K212896 is an FDA 510(k) clearance for the Visible Patient Suite. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Visible Patient, Sas (Strasbourg, FR). The FDA issued a Cleared decision on November 5, 2021, 56 days after receiving the submission on September 10, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K212896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2021 |
| Decision Date | November 05, 2021 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |