K254089 is an FDA 510(k) clearance for the IOPS Visionary System (MC-3). This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Centerline Biomedical, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 17, 2026, 60 days after receiving the submission on December 19, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K254089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2025 |
| Decision Date | February 17, 2026 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |