← Product Code [DXX](/productcode/DXX) · K262744

# GenesisX RMN (K262744)

_Stereotaxis, Inc. · DXX · Aug 27, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262744

## Device Facts

- **Applicant:** Stereotaxis, Inc.
- **Product Code:** [DXX](/productcode/DXX.md)
- **Decision Date:** Aug 27, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1290
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

---

**Source:** [https://fda.innolitics.com/device/K262744](https://fda.innolitics.com/device/K262744)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com