| K-number | K253473 |
| Device name | Synchrony |
| Applicant | Stereotaxis, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Apr 1, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
The Stereotaxis Synchrony system is an optional display and user interface software package designed for catheter laboratories. It consolidates control of multiple lab devices onto a single screen with one keyboard and mouse, simplifying the user interface and streamlining clinical workflows.
The main technical differences from the predicate Odyssey devices are improvements in image processing, video transfer, and system communication. Synchrony maintains the same display monitor and user interface design allowing clinicians to view multiple diagnostic tool screens.
Design verification and validation testing followed ISO 14971 risk analysis, IEC 60601-1 electrical safety standards, and IEC 60601-1-2 electromagnetic compatibility standards. Testing included electrical safety, functional performance, and cybersecurity penetration tests.
Synchrony has the same intended use and is substantially equivalent in design and functionality to the predicate devices Odyssey (K072371, cleared 2007) and Odyssey (K093092, cleared 2010). The modifications to image processing, video transfer, and system communication do not introduce different questions about safety or effectiveness. Bench testing demonstrated that Synchrony meets specifications and performs as intended with no new safety or performance issues.
View the full FDA submission: accessdata.fda.gov