Regulatory filing

fda_510k (us_fda)

FDA 510(k) clearance for GenesisX Robotic Magnetic Navigation System. Latest generation endovascular surgical robotics.

fda 510k · cleared · decided 2024-01-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2024-01-01
Decision date: 2024-01-01
Verification posture: verified

Applicant

Covered models (1)

Genesis RMN / GenesisX

Sources (1)

https://ir.stereotaxis.com/news-releases/news-release-details/genesisx-robotic-magnetic-navigation-system-receives-us-fda

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Identity

ece80fae-a627-4064-91e1-8deffb9470e8