Regulatory Approvals and Data Security

Regulatory Approvals

FDA 510(k) Clearance (K131596)

AAMI ES 60601-1:2005/(R)2012 (Medical electrical equipment – Basic safety and essential performance)

IEC 60601-1-6:2010+A1:2013 (Medical electrical equipment – Usability)

IEC 62304:2006 (Medical device software – Software life cycle processes)

IEC 60601-1-2:2007 (Medical electrical equipment – Electromagnetic compatibility)

IEC 60825-1:2007-03 (Safety of laser products)

CDRH 21CFR1040.10 (Performance standards for light-emitting products)

Data Security

HIPAA-compliant

SOC II Compliant Private Data Center