# fda_510k (us_fda)

Stereotaxis next-generation endovascular surgical robot receives FDA 510(k) clearance.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Decision date: 2025-11-10

## Covered models (1)

- [Genesis RMN / GenesisX](/models/stereotaxis-genesis.md)

## Sources (1)

- [https://www.dicardiology.com/content/stereotaxis-next-gen-endovascular-surgical-robot-receives-510k-clearance-fda](https://www.dicardiology.com/content/stereotaxis-next-gen-endovascular-surgical-robot-receives-510k-clearance-fda)

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