Regulatory filing

fda_510k (us_fda)

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

fda 510k · cleared · decided 2025-11-10

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Decision date: 2025-11-10

Covered models (1)

Genesis RMN / GenesisX

Sources (1)

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

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Identity

820c676d-3a71-459e-9dba-b580b2b48678