Regulatory Information

Levo Gen 2 was designed and developed in accordance with federal regulations, FDA recommendations, and industry best practices regarding cybersecurity. For cybersecurity information regarding this medical device, including:

  • Recommended cybersecurity controls for the intended use environment
  • Diagrams that allow recommended cybersecurity controls to be implemented
  • Port information, including functionality
  • Infrastructure requirements
  • Updating and Patchability
  • Security event response
  • Device features protecting critical functionality
  • Retention and recovery methods
  • Secure configuration
  • Logging information
  • End of Support/End of Component information
  • Secure decommissioning information

Please click here: www.levomedical.com/labeling/

Additional cybersecurity labeling information for the Levo Gen 2 is provided in a revision-controlled Manufacturer Disclosure Statement for Medical Devices (MDS2), located at: www.levomedical.com/MDS2/

For information on third-party components in the Levo Gen 2 system, a revision-controlled Software Bill of Materials is provided to users at: www.levomedical.com/SBOM/

Levo Gen 2 users are encouraged to contact Levo with any questions or reports of suspected cybersecurity vulnerabilities or incidents through email at support@levomedical.com, or through Levo’s Coordinated Vulnerability Disclosure (CVD) process. More information on Levo’s CVD process can be found here: www.levomedical.com/CVD/


Coming Soon. Levo Gen 2 is currently not available in the US, pending FDA 510(k) Clearance. Levo Gen 1 is still available in the US.